Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Summary

This phase II trial studies how well the combination of botensilimab, balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps to slow or stop the spread of tumor cells. The combination of botensilimab, balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer.

Conditions

• Advanced Colon Adenocarcinoma
• Advanced Colorectal Adenocarcinoma
• Advanced Rectal Adenocarcinoma
• Metastatic Colon Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma
• Metastatic Rectal Adenocarcinoma
• Stage III Colon Cancer AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8
• Stage IV Colon Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IV Rectal Cancer AJCC v8

Interventions

BIOLOGICAL

Balstilimab

Given IV

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Botensilimab

Given IV

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Regorafenib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Marwan G Fakih · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2027-01-28

Completion

2027-01-28

FDA Drug

Yes