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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05627635
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo a blood sample collection
  • Botensilimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo a CT scan
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Oxaliplatin — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo a PET scan
  • X-Ray Imaging — PROCEDURE
    Undergo an x-ray

Study Details

This phase I/II trial tests the safety, side effects, best dose, and efficacy of FOLFOX and bevacizumab in combination with botensilimab and balstilimab (3B-FOLFOX) in treating patients with microsatellite stable (MSS) colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as FOLFOX, 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. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Balstilimab and botensilimab are in a class of medications called monoclonal antibodies. They bind to proteins, called PD-L1 and CTLA-4, which is found on some types of tumor cells. These PD-1 and CTLA-4 proteins are known to affect the body's defense mechanism to identify and fight against tumor cells. The combination of these drugs may lead to improved disease control and outcomes in patients with MSS metastatic colorectal cancer.

Key Dates

Start date
May 3, 2023
Status verified
Nov 2025
Primary completion
Jun 23, 2026
Completion
Jun 23, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I (3B-FOLFOX)
    Patients receive FOLFOX, bevacizumab, balstilimab, and botensilimab IV on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
  • Experimental: Phase II, Arm I (3B-FOLFOX)
    Patients receive FOLFOX, bevacizumab and balstilimab IV with botensilimab IV at a lower dose on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.
  • Experimental: Phase II, Arm II (3B-FOLFOX)
    Patients receive FOLFOX, bevacizumab and balstilimab IV with botensilimab IV at a higher dose on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.

Primary Outcome Measure

Incidence of adverse events (phase I) [ Time Frame: Up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-

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By research site
City of Hope Medical Center· Duarte, CA

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