FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 3, 2023

Primary Completion Date

October 7, 2025

Study Completion Date

October 7, 2025

Conditions
Metastatic Colon AdenocarcinomaMetastatic Colorectal AdenocarcinomaMetastatic Microsatellite Stable Colorectal CarcinomaMetastatic Rectal AdenocarcinomaStage IV Colon Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Rectal Cancer AJCC v8
Interventions
BIOLOGICAL

Balstilimab

Given IV

BIOLOGICAL

Bevacizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo a blood sample collection

BIOLOGICAL

Botensilimab

Given IV

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Oxaliplatin

Given IV

PROCEDURE

Positron Emission Tomography

Undergo a PET scan

PROCEDURE

X-Ray Imaging

Undergo an x-ray

Trial Locations (1)

91010

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER