Gastrointestinal

Colorectal:

CIRB #H-37277/ CTSU #A021502: Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

CIRB #H-39558/ CTSU #A021703 (SOLARIS): Randomized Double-Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

CIRB #pend/ CTSU #A221805: Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study (not yet submitted to IRB)

Neuroendocrine:

CIRB #H-38045 / CTSU #A021602 (CABINET):  Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus

Anal:

CIRB #H-38309/ CTSU #EA2165: A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

CIRB #H-39855/ CTSU #EA2182 (DECREASE): A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)

Liver/Bile Ducts:

HIRB #2019-51/ Merck #KEYNOTE-937: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)

HIRB #2019-56/ Incyte #INCB-302 (FIGHT-302): A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement

Central IRB #H-38983/ Lexicon #1606-207 (TELE-ABC): A Phase 2, Multicenter, Open-label, Safety and Efficacy Study of XERMELO® (Telotristat Ethyl) Plus First-line Chemotherapy in Patients With Locally Advanced, Unresectable, Recurrent or Metastatic Biliary Tract Cancer (BTC) (TELE-ABC: Telotristat Ethyl for Advanced Biliary Tract Cancer)

Pancreatic Cancer:

CIRB #pend/ CTSU #A021806:A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer (not yet submitted to IRB)

Central IRB #H-39081/ NGM #18-0402: A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (temporary closure)

Last line Colorectal, Gastric, Esophageal, or Pancreatic Cancers:

Central IRB #H-39081/ NGM #18-0402: A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy (limited enrollment)

GI Cancers:

IRB #H-38168/ DFCI El Centro: Engaging Latinos in the Center of Cancer Treatment options – RCT of Usual Chemotherapy Educational Tools Versus Investigational Chemotherapy Educational Tools (temporary closure during COVID pandemic)