Clinical Trials

UofL Health -- Brown Cancer Center has one goal – To End Cancer

This commitment involves conducting clinical trials with the goal of helping patients live longer, healthier lives. Through clinical studies, researchers can better understand how to diagnose, treat and prevent diseases or conditions. Any time you or a loved one needs treatment for cancer, clinical trials are an option to think about. Through the clinical trials at UofL Health -- Brown Cancer Center, doctors find new ways to improve treatments and quality of life for people with cancer.

Patients have access to new treatments, sometimes those that are not available anywhere else. Trials are available for all stages of cancer. It is a myth that clinical trials are only for people who have advanced cancer that is not responding to any other treatment; our clinical trial program features trials for all stages of disease.

Our researchers and physicians design cancer trials to test new ways to treat cancer, find and diagnose cancer, prevent cancer and manage symptoms of cancer and side effects from treatment. 

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What are clinical trials? 

Clinical trials bring us closer to the day when all cancer patients can become survivors. If you’re interested in exploring new treatment options that may also light the path to better treatments for other patients, a clinical trial may be the right option for you. Speak with your doctor.

View the list below to learn more about active clinical trials at Brown Cancer Center or call 502-562-HOPE (4673).

To learn more about qualifications and enrolling in a clinical trial:

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1
 

13.0538 - A Phase I/ II Study of Hypofractionated Radiotherapy with Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old with Newly Diagnosed Glioblastoma

Principal Investigator: Shiao Y Woo, M.D., FACR, FRCP

Description: In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.

Phase: I/II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01985087?term=NCT01985087&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.
 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

21.0460: Phase 2 Study of Palliative Radiation in Combination with Pembrolizumab in Subjects with Unresectable/Metastatic Stage IV Breast Cancer

Principal Investigator: Elizabeth Riley, MD, FACP

Phase: II

Description: This is a phase 2, open-label, single-arm trial designed to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) in combination with pembrolizumab following disease progression after two prior lines of standard therapy in unresectable metastatic stage IV breast cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT04990921?term=twisted+pink&draw=2&rank=1

                                                                          

20.0726:  TENACITY: A Phase 2, Multicenter, Open-label, Single-arm Study of AL101 Monotherapy in Patients with Notch-activated Triple Negative Breast Cancer

Principal Investigator: Elizabeth Riley, MD, FACP

Phase:  II

Description:  The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.

More info:  https://clinicaltrials.gov/ct2/show/NCT04461600?term=NCT04461600&draw=2&rank=1

20.0922: A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Principal Investigator: Elizabeth Riley, MD, FACP

Phase:  II

Description:  This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer.Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.

More info:  https://clinicaltrials.gov/ct2/show/NCT04539938?term=NCT04539938&draw=2&rank=1

19.0667:  An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected with a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)

Principal Investigator: Elizabeth Riley, M.D., FACP

Phase:  II

Description:  This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity HSF testing.

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0495: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Principal Investigator: Harriet Eldredge-Hindy,  MD

Phase:  III

Description: The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

More info: https://clinicaltrials.gov/ct2/show/NCT03488693?term=NCT03488693&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 
 

18.0725:  A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2–) Breast Cancer (KEYNOTE-756)        

Principal Investigator:  Elizabeth Riley, M.D., FACP    

Description: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.     

Phase:  III    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03725059?term=NCT03725059&rank=1 

18.0999: Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer         

Principal Investigator:  Elizabeth Riley, M.D., FACP  

Description:  This research study is studying three combinations of drugs as treatments for breast cancer.  The drugs involved in this study are:

  •     Fulvestrant
  •     Fulvestrant with Palbociclib
  •     Fulvestrant with Palbociclib and Avelumab    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03147287?term=NCT03147287&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1
 

15.0596 - A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318)

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.1129:  A GLOBAL, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED PHASE 3 TRIAL TO COMPARE THE EFFICACY AND SAFETY OF FRUQUINTINIB PLUS BEST SUPPORTIVE CARE TO PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH REFRACTORY METASTATIC COLORECTAL CANCER (FRESCO-2)

Principal Investigator: Vivek Sharma, MD, FACP

Phase:  3

Description:  This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). Approximately 520 subjects will be randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

More Info:  https://clinicaltrials.gov/ct2/show/NCT04322539?term=NCT04322539&draw=2&rank=1

20.1013: A Multicenter, Open-label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

Principal Investigator: Vivek Sharma, MD, FACP

Phase: III

Description: The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study.This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

More info: https://clinicaltrials.gov/ct2/show/NCT03486873?term=NCT03486873&draw=2&rank=1

20.0927:  PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Principal Investigator: Adam Rojan, MD

Phase:  III

Description:  This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

More info:  https://clinicaltrials.gov/ct2/show/NCT04340141?term=NCT04340141&draw=2&rank=1

20.0359: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination with Trans-arterialChemoEmbolization (TACE) in Patients with Intermediate-stage Hepatocellular Carcinoma(HCC) (CheckMate 74W: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 74W)

Principal Investigator: Vivek Sharma, MD, FACP

Phase: III

Description: The purpose of this study is to compare effectiveness and safety of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer

More Info: https://clinicaltrials.gov/ct2/show/NCT04340193?term=NCT04340193&draw=2&rank=1

20.0120:  A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma(LEAP-012)

Principal Investigator: Adam Rojan, MD

Phase:  III

Description:  The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

More info:  https://clinicaltrials.gov/ct2/show/NCT04246177?term=NCT04246177&draw=2&rank=1

19.0779:  A Phase 3 Randomized, Open-label Study to evaluate the efficacy and safety of Olaparib alone or in combination with Bevacizumab compared to Bevacizumab with 5-FU in participants with Unresectable or Metastatic Colorectal Cancer who have not progressed following first-line induction of FOLFOX with Bevacizumab (LYNK-003)

Principal Investigator: Vivek Sharma, MD, FACP

Phase:  III

Description:  This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with Fluorouracil (5-FU) in participants with unresectable or metastatic colorectal cancer (CRC) who have not progressed following first-line induction of FOLFOX with bevacizumab. Hypothesis 1 - Olaparib + Bevacizumab is superior to 5-FU + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in the treatment of CRC. Hypothesis 2 - Olaparib is superior to 5-FU + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR) in the treatment of CRC.

More info:  https://clinicaltrials.gov/ct2/show/NCT04456699?term=LYNK-003&draw=2&rank=1

19.0947:  A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy

Principal Investigator: Rebecca Redman, MD

Phase:  I

Description:  To determine the RP2D(s) of intratumorally injected NBTXR3 activated by radiotherapy (RT) in combination with an anti-PD-1 therapy (hereafter referred to as R3/RT/PD-1).

More info:  https://clinicaltrials.gov/ct2/show/NCT03589339?term=NCT03589339&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0450:  P1719-SUR-Z11 A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumors.

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description:  This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

More info:  https://clinicaltrials.gov/ct2/show/NCT03836352?term=NCT03836352&draw=2&rank=1

19.0666: A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plus Cisplatin for Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1)

Principal Investigator: Vivek Sharma, MD, FACP

Phase: III

Description: A Global Phase III Study of durvalumab or placebo in combination with gemcitabine/cisplatin in patients with 1st line advanced biliary tract cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT03875235?term=NCT03875235&draw=2&rank=1

19.0721:  Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Principal Investigator: Scott Silva, MD, PhD

Phase:  III

Description:  This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

More info:  https://clinicaltrials.gov/ct2/show/NCT03678025?term=NCT03678025&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

13.0205 - Preemptive therapy of Cetuximab (Erbitux) induced skin rash using doxycycline, sunscreen, hydrocortisone, and moisturizer in colorectal and head and neck cancer patients.

Principal Investigator: Rebecca Redman, M.D.

Description: The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01874860?term=NCT01874860&rank=1
 

10.0628 - Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue. 

Principal Investigator: Kelli Dunn, M.D.

Description: This clinical trial will investigate the ability of plant exosomes to more effectively deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of turmeric, a natural product with diverse biological activities. Exosomes are small endosome-derived vesicles (50-100 nanometers [nm] in size). Previous clinical trials conducted with oral curcumin have demonstrated only limited bioavailability even at very high doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by using plant exosomes to deliver the drug to colon tumors and normal colon tissue.

Phase: I

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01294072?term=NCT01294072&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.1093 : Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of CareTherapy as First-line Intervention in Participants with Advanced/Metastatic GastroesophagealAdenocarcinoma (LEAP-015)

Principal Investigator: Vivek Sharma, MD, FACP

Phase:  III

Description:  The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

 

More Info: https://clinicaltrials.gov/ct2/show/NCT04662710?term=NCT04662710&draw=2&rank=1                                                                                       

 

20.1169: Phase 3, Randomized, Open-label Study to Evaluate PerioperativeEnfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine andCisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer(KEYNOTE-B15 / EV-304)

Principal Investigator: Rohit Kumar MD

Phase:  III

Description:  The trial is being done to: •      See if EV + pembro before and after surgery is more effective than Gemcitabine + Cisplatin before surgery. This will be measured by tissue samples that are taken during surgery and images taken at different times. •         Test the safety of EV + pembro before + after surgery.•            See how well your body handles EV + pembro before and after surgery.•  See if participants who get EV + pembro before and after surgery live longer compared to those who get Gemcitabine + Cisplatin before surgery. •        Look at the participant’s quality of life.

More info:  https://clinicaltrials.gov/ct2/show/NCT04700124?term=NCT04700124&draw=2&rank=1 

20.0130:  Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer.

Principal Investigator: Vikas Singh, MD

Phase:  III

Description:  This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

More info: https://clinicaltrials.gov/ct2/show/NCT03775265?term=NCT03775265&draw=2&rank=1

19.0626:  A Prospective Comparative Study of Outcomes with Proton and Photon Radiation in Prostate Cancer (Compare)

Principal Investigator: Scott Silva, MD, PhD

Description:  This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.

More info:  https://clinicaltrials.gov/ct2/show/NCT03561220?term=NCT03561220&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0450:  P1719-SUR-Z11 A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumors.

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description:  This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

More info:  https://clinicaltrials.gov/ct2/show/NCT03836352?term=NCT03836352&draw=2&rank=1

19.0721:  Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Principal Investigator: Scott Silva, MD, PhD

Phase:  III

Description:  This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

More info:  https://clinicaltrials.gov/ct2/show/NCT03678025?term=NCT03678025&rank=1

19.0728: Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

Principal Investigator: Scott Silva,  MD, PhD

Phase:  III

Description:  This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

More info:  https://clinicaltrials.gov/ct2/show/NCT03367702?term=NCT03367702&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0450:  P1719-SUR-Z11 A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumors.

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description:  This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

More info:  https://clinicaltrials.gov/ct2/show/NCT03836352?term=NCT03836352&draw=2&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

18.0874: A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer.       

Principal Investigator: Scott Silva, M.D. 

Description:  This randomized phase II trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.    

Phase:  II    

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02466971?term=NCT02466971&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

18.0160:  A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic or Persistent Cervical Carcinoma    

Principal Investigator:  Jason A Chesney, M.D., Ph.D.    

Description: LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.     

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03108495?term=NCT03108495&rank=1  
 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.1144: PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND  CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA(ASPEN-04)

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description:  This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.

More info:    https://clinicaltrials.gov/ct2/show/NCT04675333?term=NCT04675333&draw=2&rank=1 

20.0749: RANDOMIZED PHASE II/III TRIAL OF SENTINEL LYMPH NODE BIOPSY VERSUS ELECTIVE NECK DISSECTION FOR EARLY-STAGE ORAL CAVITY CANCER

Principal Investigator: Neal Dunlap, MD

Phase:  II/III

Description:  This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.

More info: https://clinicaltrials.gov/ct2/show/NCT04333537?term=NCT04333537&draw=1&rank=1

19.1115: A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Optimal Dose, Safety, and Activity of AAV2hAQP1 in Subjects With Radiation-Induced Parotid Gland Hypofunction and Xerostomia

Principal Investigator: Neal Dunlap, MD

Phase: I/II

Description: Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single parotid gland in subjects with radiation-induced xerostomia The objectives are to evaluate the safety and identify either a maximum tolerated dose or a maximum feasible dose of a single dose of AAV2hAQP1 infused into one targeted parotid gland:To evaluate subject improvement of xerostomia symptoms, to evaluate the increase in parotid gland salivary output after treatment with AAV2hAQP1, to evaluate additional efficacy outcomes.

More Info: https://clinicaltrials.gov/ct2/show/NCT04043104?term=NCT04043104&draw=2&rank=1

13.0369:  RANDOMIZED PHASE II/III TRIAL OF ADJUVANT RADIATION THERAPY WITH CISPLATIN, DOCETAXEL-CETUXIMAB, OR CISPLATIN-ATEZOLIZUMAB IN PATHOLOGIC HIGH-RISK SQUAMOUS CELL CANCER OF THE HEAD AND NECK

Principal Investigator: Neal Dunlap, MD

Phase:  III

Description:  This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

More info:  https://clinicaltrials.gov/ct2/show/NCT01810913?term=NCT01810913&draw=2&rank=1

19.1211:  A Phase 3, randomized, placebo-controlled, double-blind clinical study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) to evaluate the safety and efficacy of pembrolizumab and lenvatinib as 1L intervention in a PD-L1 selected population of participants with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) (LEAP-010).

Principal Investigator: Rebecca Redman, MD

Phase:  III

Description:  This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

More info:  https://clinicaltrials.gov/ct2/show/NCT04199104?term=NCT04199104&draw=2&rank=1

19.1216:  A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

Principal Investigator: Rebecca Redman, MD

Phase:  III

Description:  This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT03811015?term=NCT03811015&draw=2&rank=1

19.0947:  A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy

Principal Investigator: Rebecca Redman, MD

Phase:  I

Description:  To determine the RP2D(s) of intratumorally injected NBTXR3 activated by radiotherapy (RT) in combination with an anti-PD-1 therapy (hereafter referred to as R3/RT/PD-1).

More info:  https://clinicaltrials.gov/ct2/show/NCT03589339?term=NCT03589339&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0829: A randomized phase II/III trial of de-intensified radiation therapy for patients with early stage, P16-postivite, non-smoking associated oropharyngeal cancer

Principal Investigator: Neal Dunlap, MD

Phase: II

Description: This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT03952585?term=NCT03952585&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

19.0269: Phase II randomized trial of neo-adjuvant chemotherapy followed by surgery and post-operative radiation versus surgery and post-operative radiation for organ preservation of T3 and T4a nasal and paranasal sinus squamous cell carcinoma (NPNSCC)       

Principal Investigator: Neal Dunlap, M.D.     

Description:  This randomized phase II trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer that can be removed by surgery. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03493425?term=NCT03493425&rank=1 

19.0260: Phase II Randomized Trial of Radiotherapy with or without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing       

Principal Investigator:  Rebecca Redman, M.D.

Description: This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.     

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02734537?term=NCT02734537&rank=1 

18.1104: KEYSTROKE: A Randomized Phase II Study of Pembrolizumab (KEYTRUDA®) Plus Stereotactic Re-irradiation Versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma     

Principal Investigator:  Neal Dunlap, M.D. 

Description:  This phase II trial with a safety run-in component will evaluate whether the addition of pembrolizumab to Stereotactic Body Radiation Therapy (SBRT) re-irradiation will improve the progression-free survival for patients with recurrent or new second primary Head and Neck Squamous Cell Carcinoma (HNSCC).    

Phase:  II    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT03546582?term=NCT03546582&rank=1 

18.0336:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 
 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.0313: A PHASE 3 MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ROZANOLIXIZUMAB IN ADULT STUDY PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA (ITP)

Principal Investigator: Kamila Cisak, MD

Phase:  III

Description:  The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and asses safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

More info: https://clinicaltrials.gov/ct2/show/NCT04200456?term=NCT04200456&draw=2&rank=1

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.0331:  PHASE III STUDY OF DARATUMUMAB/rHuPH20 (NSC- 810307) + LENALIDOMIDE OR LENALIDOMIDE AS POST-AUTOLOGOUS STEM CELL TRANSPLANT MAINTENANCE THERAPY IN PATIENTS WITH MULTIPLE MYELOMA (MM) USING MINIMAL RESIDUAL DISEASE TO DIRECT THERAPY DURATION (DRAMATIC STUDY)

Principal Investigator: Ju-Hsein (John) Chao, D.O.

Phase:  III

Description:  Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

More info:  https://clinicaltrials.gov/ct2/show/NCT04071457?term=NCT04071457&draw=2&rank=1

20.0325:  Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

Principal Investigator: Ju-Hsein (John) Chao, D.O.

Phase:  III

Description:  This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma. 

More info:  https://clinicaltrials.gov/ct2/show/NCT03937635?term=NCT03937635&draw=2&rank=1

20.0198:  A PHASE IB TRIAL OF NEOADJUVANT AMG 232 CONCURRENT WITH PREOPERATIVE RADIOTHERAPY IN WILD-TYPE P53 SOFT TISSUE SARCOMA (STS)

Principal Investigator: Vikas Singh, MD

Phase:  I

Description:  This phase Ib trial studies the side effects of MDM2 inhibitor AMG-232 and radiation therapy in treating patients with soft tissue sarcoma. MDM2 inhibitor AMG-232 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving MDM2 inhibitor AMG-232 and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

More info:  https://clinicaltrials.gov/ct2/show/NCT03217266?term=NCT03217266&draw=2&rank=1

19.0403: A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients with Refractory or Relapsed AML

Principal Investigator: Mohamed Hegazi, M.D.

Phase:  I/II

Description: The study is a multicenter, open label Phase I/II trial. Phase 1: To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. Phase 2: To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies.

More info:  https://clinicaltrials.gov/ct2/show/NCT03867682?term=LIN-AC225-AML02&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0757: A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission

Principal Investigator: Mohamed Hegazi, M.D.

Phase:  III

Description:  This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

More info:  https://clinicaltrials.gov/ct2/show/NCT03267433?term=NCT03267433&draw=2&rank=1

19.0281: A randomized double-blind phase III study of ibrutinub during and following autologous stem cell transplantation vs. placebo inpatients with relapsed or refractory diffuse large b-cell lymphoma of the activated b-cell subtype.

Principal Investigator: Mohamed Hegazi, M.D.

Phase:  III

Description:  This randomized phase III trial studies ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma.

More info:  https://clinicaltrials.gov/ct2/show/NCT02443077?term=NCT02443077&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH)

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

12.0471 - A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients.

Principal Investigator: Mohamed Hegazi, M.D.

Description: This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Phase: II

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01656603?term=NCT01656603&rank=1
 

11.0445 - A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications.

Principal Investigator: Mohamed Hegazi, M.D.

Description: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.  The primary aim of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Phase: N/A

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01351545?term=NCT01351545&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

03.0165 - NMDP Research Sample Repository for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation.

Principal Investigator: Ju-Hsien (John) Chao, D.O.

Description: This protocol will collect blood samples and medical information from patients who have had a bone marrow transplant using cells from an unrelated donor identified through the National Marrow Donor Program (NMDP).  Patients who have received a bone marrow transplant at the NIH or other institution from an unrelated donor affiliated with the NMDP may be eligible for this study

 Additional Information: http://clinicaltrials.gov/ct2/show/NCT00495300?term=NCT00495300&rank=1

03.0158 - National Marrow Donor Program Research Database for Hematopoietic Stem Cell Transplantation.

Principal Investigator: Ju-Hsien (John) Chao, D.O.

Description: The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation.   A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01166009?term=NCT01166009&rank=1
 

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

08.0041:  Beta-glucan`s Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Principal Investigator: Phuong Ngo, MD

Description:  The overall goal of this study is to lay the groundwork for eventual research into the utility of oral beta-glucan in patients receiving Cetuximab. Patient participation will be separated into two groups. AIM 2 will enroll 150 patients with suspected or confirmed with NCSLC. These patients will take beta-glucan 250 mg TID for 14 days. Blood samples will be collected at baseline and after treatment. AIM 3 will enroll 150 patients who have resectable NCSLC. This group will receive beta-glucan 250 mg TID for 10 to 20 days before resection of lung tumor. Blood samples will be collected at baseline and after treatment (prior to surgery), and tissue will be collected during resection.

More info: https://clinicaltrials.gov/ct2/show/NCT00682032?term=NCT00682032&draw=2&rank=1

20.0986:  A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes(LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer

Principal Investigator: Jason Chesney, MD, PhD

Phase:  II

Description:  This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic NSCLC.

More info:  https://clinicaltrials.gov/ct2/show/NCT04614103?term=NCT04614103&draw=2&rank=1

20.0535: MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Principal Investigator: Neal Dunlap, MD

Phase: III

Description: This phase III trial studies magnetic resonance imaging (MRI) surveillance and prophylactic cranial irradiation (PCI) to see how well they work compared to MRI surveillance alone in treating patients with small cell lung cancer. MRI scans are used to monitor the possible spread of the cancer with an MRI machine over time. PCI is radiation therapy that is delivered to the brain in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. Monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) may be at least as good as the combination of PCI with MRI scans.

More info: https://clinicaltrials.gov/ct2/show/NCT04155034?term=NCT04155034&draw=2&rank=1

20.0209: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an anti-TIM-3 Monoclonal Antibody, in Patients with Advanced Solid Tumors (AMBER)

Principal Investigator: Jason A Chesney, MD, PhD

Phase:  I

Description:  This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-TIM-3 (T cell immunoglobulin and mucin containing protein-3) antibody TSR-022, as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced solid tumors. The study will be conducted in 2 parts: dose escalation and cohort expansion.

More info:  https://clinicaltrials.gov/ct2/show/NCT02817633?term=NCT02817633&draw=2&rank=1

20.0015: Limited Stage Small Cell Lung Cancer (LS-SCLC): A PHASE II/III RANDOMIZED STUDY OF CHEMORADIATION VERSUS CHEMORADIATION PLUS ATEZOLIZUMAB

Principal Investigator: Neal Dunlap, MD

Phase: II

Description: This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

More info: https://clinicaltrials.gov/ct2/show/NCT03811002?term=NCT03811002&draw=2&rank=1

19.0947:  A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy

Principal Investigator: Rebecca Redman, MD

Phase:  I

Description:  To determine the RP2D(s) of intratumorally injected NBTXR3 activated by radiotherapy (RT) in combination with an anti-PD-1 therapy (hereafter referred to as R3/RT/PD-1).

More info:  https://clinicaltrials.gov/ct2/show/NCT03589339?term=NCT03589339&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

19.0450:  P1719-SUR-Z11 A Phase 2, Open-label, Multicenter, Study of an Immunotherapeutic Treatment, DPX-Survivac in combination with Low Dose Cyclophosphamide and Pembrolizumab, in Subjects with Selected Advanced and Recurrent Solid Tumors.

Principal Investigator: Rebecca Redman, MD

Phase:  II

Description:  This study will assess the safety and efficacy of DPX-Survivac and low dose cyclophosphamide with pembrolizumab in subjects with selected advanced and recurrent solid tumours.

More info:  https://clinicaltrials.gov/ct2/show/NCT03836352?term=NCT03836352&draw=2&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

18.0336:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.II

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.1138 - A Randomized Phase III Study of Sublobar Resection (SR) versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC).

Principal Investigator:  Neal Dunlap, M.D.

Description:  Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR. Informed consent will be obtained after patients are made aware of the randomized assignment. Despite pre-randomization prior to consent, patients maintain their right to accept or decline any/all study activities. Only consenting patients will be allowed to participate in study activities, including observation after either randomized treatments or observation after standard of care treatment, while those declining consent will be managed by their physician(s) off study.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02468024
 

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

IRB Number:  15.0596

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

15.0122 - CIRB - A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein.

Principal Investigator:  Jason Chesney, M.D., Ph.D.

Description:  This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.

Phase:  III

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02201992

15.0075 - Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).

Principal Investigator:  Jason Chesney, M.D., Ph.D.

Description:  This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02194738

13.0337 - The effect of pentoxifylline and Vitamin E in preventing radiation-induced toxicity in the treatment of recurrent or new primary non-small cell lung cancers using stereotactic ablative radiotherapy (SABR) in patients previously treated with thoracic radiation.

Principal Investigator: Neal Dunlap, M.D. 

Description: The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers.

Additional Information: http://clinicaltrials.gov/ct2/show/NCT01871454?term=NCT01871454&rank=1
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1

20.1176: A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma

Principal Investigator: Jason Chesney, MD, PhD

Phase:  II

Description:  DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

Learn more here:  https://clinicaltrials.gov/ct2/show/NCT05050006?term=NCT05050006&draw=2&rank=1                              

19.1041: A Phase 4 Pan-Tumor Study of Long Term Follow up for Cancer Survivors treated with Nivolumab or Nivolumab Combination Therapy

Principal Investigator: Jason A Chesney, MD, PhD

Phase: IV

Description: Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

More info: https://clinicaltrials.gov/ct2/show/NCT03899155?term=NCT03899155&draw=2&rank=1

18.1095: Neoadjuvant combination immunotherapy for stage III melanoma

Principal Investigator: Michael M Egger, M.D.

Phase:  II

Description:  Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.

More info:  https://clinicaltrials.gov/ct2/show/NCT03842943?term=NCT03842943&draw=2&rank=1

19.0698:  Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination with Pembrolizumab in Advanced Cancer

Principal Investigator: Rebecca Redman, M.D.

Phase:  I

Description: This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in two parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.

More Info:  https://clinicaltrials.gov/ct2/show/NCT03674567?term=NCT03674567&draw=2&rank=1

18.0948:  A Phase 3, Randomized, Open-label Study of NKTR-214 Combined with Nivolumab Versus Nivolumab in Participants with Previously Untreated Unresectable or Metastatic Melanoma

Principal Investigator: Jason A Chesney, MD, PhD

Phase:  III

Description:  The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

More info:  https://clinicaltrials.gov/ct2/show/NCT03635983?term=NCT03635983&draw=2&rank=1

18.1191: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Principal Investigator: Jason A Chesney, MD, PhD

Phase: II

Description: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03767348?term=NCT03767348&rank=1

19.0032A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 404, a Programmed Death-1 (PD-1) Antibody, in Patients with Advanced Solid Tumors

Principle Investigator: Jason A Chesney, MD, PhD

Phase: I

Description: To evaluate the safety and tolerability of AMG 404 in patients with advanced solid tumors.

More Info: https://clinicaltrials.gov/ct2/show/NCT03853109?term=NCT03853109&rank=1

17.1155: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, in Patients With Advanced Solid Malignancies and Lymphoma With an Expansion in Select Malignancies     

Principal Investigator: Rebecca Redman, M.D.     

Description: Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-104, an oral small molecule targeting the liver X receptor (LXR). RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells (MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other cells of the immune system from attacking tumors.     

Phase:  I    

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02922764?term=NCT02922764&rank=1 

18.0336:  A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes
(LN-144 or LN-145) in Patients with Solid Tumors    

Principal Investigator:  Jason A Chesney, MD, PhD

Description:  A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with pembrolizumab. TIL as a single-therapy will be evaluated with LN-145 only.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&rank=1 

16.0817 - A Phase 2, Multicenter, Single-arm Study to Assess the Safetyand Efficacy of Cell Transfer Therapy Using Autologous Tumor Infiltrating Lymphocytes (LN-144) Followed by IL-2 for Treatment of Patients with Metastatic Melanoma.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  LN-144 is a cell transfer therapy and is based on current TIL therapy regimens originally developed by the NCI for the treatment of patients with metastatic melanoma. The cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients will be evaluated for response approximately 12 weeks following the LN-144 therapy. Patients will receive one course of treatment.    

Phase: II     

Additional Information:  https://clinicaltrials.gov/ct2/show/NCT02360579?term=C-144-01&rank=1
 

16.0568 - Molecular Analysis for Therapy Choice (MATCH).

Principal Investigator: Vivek Sharma, M.D., F.A.C.P.

Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase: II

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02465060?term=eay131&rank=1

15.0596 - A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors.

Principal Investigator:  Jason A Chesney, M.D., Ph.D.

Description:  This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.

Phase:  I

Additional Information: https://clinicaltrials.gov/ct2/show/NCT02509507
 

08.0388 - Protocol for the Cancer Database and Specimen Repository (CDSR) at the Brown Cancer Center (Previous Lung Repository).

Principal Investigator: Rebecca Redman, M.D.

Description: The mission of the Cancer Database and Specimen Repository (CDSR) is to collect clinical information and samples of human specimens from cancer patients and from control patients for research, and to distribute specimens to researchers for the advancement of science.

20.0685:  NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

Principal Investigator: Rebecca Redman, MD

Phase:  N/A

Description:  This study collects blood samples, medical information, and medical images from patients who are being treated for cancer and have a positive test for SARS CoV-2, the new coronavirus that causes the disease called COVID-19. Collecting blood samples, medical information, and medical images may help researchers determine how COVID-19 affects the outcomes of patients undergoing cancer treatment and how having cancer affects COVID-19.

More info:  https://clinicaltrials.gov/ct2/show/NCT04387656?term=NCT04387656&draw=2&rank=1