Gastrointestinal

Neuroendocrine:

CIRB #H-42963/ CTSU #A022001: Phase II Randomized, Prospective Trial of Lutetium Lu 177 Dotatate PRRT Versus Capecitabine and Temozolomide in Well-Differentiated Pancreatic Neuroendocrine Tumors

WCG IRB #H-42950/ Crinetics #CRN00808-11: A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects With Carcinoid Syndrome

WCG IRB #H-41709/ DFCI #19-403: Phase II trial of cabozantinib in combination with nivolumab for advanced carcinoid tumors (temporary closure)

Advarra IRB #H-43892/ RayzeBio RYZ101-301: Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy (pending)

Colorectal:

CIRB #H-43515/ CTSU #A022104 (JANUS): The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing The Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients With Locally Advanced Rectal Cancer (pending IRB approval)

Advarra IRB #H-43651/ Nucana NuTide373: A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer (pending)

CIRB #H-44177/ NRG GI008 (CIRCULATE-US): Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (pending CIRB approval)

Anal:

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

Pancreatic:

CIRB #H-40808/ CTSU #A021806: A Phase III Trial of Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

WCG IRB #H-43572/ Genentech GO44479: A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma (pending)

IRB #H-41225/ Partners #Decision Aids: Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Stomach/Esophageal:

CIRB H-43647/ CTSU #A022102: Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma

CIRB H-42109/ CTSU #EA2174: A Phase II/III Study of Peri-operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma (temporary closure)

Metastatic/Advanced 2nd+ Line Solid Tumors:

KRAS/NRAS/HRAS/BRAF positive
CIRB #H-42956/ ETCTN #10449: A Phase 1 Study of ZEN003694 in Combination with Binimetinib in Solid Tumors with RAS Pathway Alterations and Triple Negative Breast Cancer (temporary closure)