Suspended

BMS-986340, Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Microsatellite-stable Colorectal Cancer

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What is being tested

Nivolumab

+ Bevacizumab

+ BMS-986340

Drug
Who is being recruted

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore a new treatment combination for patients with colorectal cancer that does not respond to standard treatments, specifically for those with a type called microsatellite-stable colorectal cancer. The study aims to evaluate a combination of drugs: BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab. These drugs are believed to work together to enhance the body's immune response against the cancer and to interrupt the cancer's growth process. The main goals are to assess the safety of this drug combination and to determine how well patients respond to it, potentially offering a new option for those who have exhausted other treatments. Participants in this study will receive the combination of drugs as part of their treatment regimen. The study will monitor how the body handles the drugs to ensure they are safe for use. Researchers will evaluate the effectiveness of the treatment by measuring how long patients live without the cancer getting worse, overall survival rates, and how long any positive response lasts. This study could offer valuable insights into improving treatment for this type of colorectal cancer and might lead to better outcomes for patients in the future.

Official TitlePhase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer
NCT07011550
Principal SponsorM.D. Anderson Cancer Center
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 exclusion criteria prevent from participating
Prior treatment with anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand (anti-PD-L1), anti-programmed cell death ligand 2, anti-CD137, anti-OX-40, anti CD40, anti-cytotoxic T lymphocyte associated antigen-4 antibodies, or any other immune checkpoint inhibitors
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment (to be determined by the treating physician)
Participants with symptomatic leptomeningeal disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
SLI/Exp: Treatment with BMS-986340 + Nivolumab + Trifluridine/tipiracil + Bevacizumab Q4W

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

MD Anderson Cancer Center

Houston, United StatesOpen MD Anderson Cancer Center in Google Maps
SuspendedOne Study Center