Combination Immunotherapy in Colorectal Cancer

Last updated: July 25, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Suspended

Phase

2

Condition

N/A

Treatment

Botensilimab

Balstilimab

Clinical Study ID

NCT05571293
22-09025238
  • Ages > 18
  • All Genders

Study Summary

This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • Histologically, cytologically, or clinically confirmed adenocarcinoma of the colonor rectal cancer as long as there is no plans for neoadjuvant radiation for thepatients with rectal cancer. Note: patients can enroll in cohort B while awaitingmismatch repair testing results. If noted to be dMMR/MSI-High, they would be stillconsidered evaluable and moved to cohort C.

  • If capable of becoming pregnant, or getting someone else pregnant, must be willingto use highly effective contraception from Screening period through 90 daysfollowing the last dose of study drug

Exclusion

Exclusion Criteria:

  • Metastatic cancer (cancer that has spread to other parts of the body)

  • Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1

  • Currently participating in another study and receiving a study drug

  • History of severe allergic reactions to immunotherapies

  • Pregnant or breastfeeding

  • Active infection requiring treatment

  • On immunosuppressive medications

  • Active cardiovascular disease, such as stroke or myocardial infarction within 6months of enrollment, unstable angina, congestive heart failure, or seriousuncontrolled cardiac arrhythmia requiring medication that may prevent surgery

Participants in Cohort C must be dMMR/MSI-High.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Botensilimab
Phase: 2
Study Start date:
March 17, 2023
Estimated Completion Date:
June 30, 2026

Study Description

This is a pilot study to assess the feasibility, safety, and efficacy of using a combination of a programmed cell death protein 1 (PD-1) inhibitor (balstilimab) and cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor (botensilimab) in the neoadjuvant setting in patients with colorectal cancer, prior to resection. This is a single-center, open-label, pilot study in which patients will receive 2 or 4 doses of intravenous (IV) balstilimab (each dose approximately 2 weeks apart), and a single dose of botensilimab IV, prior to resection in patients with colon cancer. Following surgical resection, participants will return to the clinic for 1-2 post-op follow-up visits.

Connect with a study center

  • Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Weill Cornell Medicine/NewYork Presbyterian - Queens

    Flushing, New York 11355
    United States

    Site Not Available

  • Weill Cornell Medicine/NewYork-Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

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