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

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

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

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

Advarra IRB #H-45290/ Takeda #TAK-113-4002: A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients from Minority Populations Underrepresented in Prior Fruquintinib Studies (pending IRB)

Pancreatic:

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

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

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

WCG IRB #H-44285/ Deciphera DCC-2618-03-003 (INSIGHT): An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib

Liver/Hepatobiliary:

Central IRB #H-44599/ AstraZeneca #EMERALD-Y90: Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy

CIRB #H-45085/ ETCTN #10608: A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

Anal:

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

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)