GASTROINTESTINAL CANCER

21.0134:  A Multicenter, Open-label, Randomized, Phase 2 Study of NT-I7 in Combination with Nivolumab versus Nivolumab Monotherapy in Subjects with Advanced or Metastatic Gastric or Gastro-Esophageal Junction or Esophageal Adenocarcinoma who Progressed on or Intolerant to 2 or more Prior Lines of Systemic Therapy

Principal Investigator: Vivek Sharma, MD, FACP

Phase:  I

Description:  The main purposes of Phase 1 (dose escalation) of this study is to determine the following in participants with gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC):Safety and tolerability of NT-I7 in combination with nivolumab Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D)The main purposes of Phase 2 of this study is to make a preliminary assessment of the antitumor activity and long-term survival of NT-I7 in combination with nivolumab in participants with gastric or GEJ or EAC.

More info:  https://clinicaltrials.gov/ct2/show/NCT04594811?term=NCT04594811&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 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

 

20.0120:  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

 

19.0698:  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

 

19.0666: 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

 

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

 

 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

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 Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (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