Study on Combination Immunotherapy for Colorectal Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05571293

Provider View

This clinical trial is testing a combination of two investigational drugs that target the immune system in people with colorectal cancer before surgery. The study aims to understand the effects and side effects of these drugs.

Patient Parameters

Program Overview

This study is exploring whether two investigational drugs, balstilimab and botensilimab, can be safely given to people with colorectal cancer before their tumors are surgically removed. Balstilimab works by blocking a protein called PD-1, and botensilimab blocks another protein called CTLA-4. Both proteins are involved in regulating the immune system. The study will also look at any side effects these drugs might cause and how they affect the cancer. Participants will be divided into three groups. Group A will receive two doses of balstilimab and one dose of botensilimab before surgery. Groups B and C will receive four doses of balstilimab and one dose of botensilimab before surgery. Group C is specifically for patients with a type of colorectal cancer known as dMMR/MSI-High.

Description

This pilot study is designed to see if a combination of two drugs, balstilimab and botensilimab, can be safely used before surgery in patients with colorectal cancer. Balstilimab blocks a protein called PD-1, and botensilimab blocks another protein called CTLA-4. Both proteins help control the immune system. The study will take place at a single center and is open-label, meaning both the researchers and participants know what treatment is being given. Participants will receive either two or four doses of balstilimab, given about two weeks apart, and one dose of botensilimab, all through an IV, before their surgery to remove the cancer. After surgery, participants will have one or two follow-up visits at the clinic to check on their recovery and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of colon or rectal cancer, as long as there are no plans for radiation treatment before surgery for rectal cancer.
  • Participants can join Group B while waiting for test results on a specific cancer marker. If they have the dMMR/MSI-High marker, they will be moved to Group C.
  • If able to become pregnant or cause pregnancy, must agree to use effective birth control from the start of the study until 90 days after the last dose of the study drug.

Exclusion Criteria

  • Cancer that has spread to other parts of the body.
  • Previous treatment with drugs that target the immune system, specifically CTLA-4, PD-1, or PD-L1.
  • Currently in another study and receiving a study drug.
  • History of severe allergic reactions to immune therapies.
  • Pregnant or breastfeeding.
  • Have an active infection that needs treatment.
  • Taking medications that suppress the immune system.
  • Have active heart disease, such as a recent stroke or heart attack, unstable chest pain, heart failure, or serious heart rhythm problems that require medication and may prevent surgery.

Participants in Group C must have the dMMR/MSI-High marker.

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