Combination Immunotherapy in Colorectal Cancer

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT05571293
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Botensilimab — DRUG
    Botensilimab, a CTLA-4 inhibitor, will be administered prior to surgical resection as described in the arm description.
  • Balstilimab — DRUG
    Balstilimab, a PD-1 inhibitor, will be administered prior to surgical resection as described in the arm description.

Study Details

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.

Key Dates

Start date
Mar 17, 2023
Status verified
Apr 2026
Primary completion
Nov 14, 2024
Completion
Jul 31, 2026

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Botensilimab and balstilimab (bot/bal)
    Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab.
  • Experimental: Cohort B:
    Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab.
  • Experimental: Cohort C:
    Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer.

Primary Outcome Measure

Cohort A and B: Pathological Overall Response (pOR) Rate Determined by Analysis of Tissue Resected During Surgery Reported by Cohort [ Time Frame: Immediately following surgical resection of the primary tumor ]

Locations (3)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist HospitalBrooklynNew York11215-
Weill Cornell Medicine/NewYork Presbyterian - QueensFlushingNew York11355-
Weill Cornell Medicine/NewYork-Presbyterian HospitalNew YorkNew York10021-

Related coverage on Hipa.ai

Find similar trials in Brooklyn, NY

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital· Brooklyn, NYWeill Cornell Medicine/NewYork Presbyterian - Queens· Flushing, NYWeill Cornell Medicine/NewYork-Presbyterian Hospital· New York, NY

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