Phase 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

Paused · Phase 2

Conditions studied: Microsatellite-stable Colorectal Cancer, Standard of Care, Nivolumab, Bevacizumab

In brief

To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.

Key facts

Study ID

NCT07011550

Run by

M.D. Anderson Cancer Center

People needed

7

Starts

2025-08-15

Expected to finish

2030-07-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior treatment with trifluridine/tipiracil, regorafenib, or fruquitinib.
• 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
• Prior organ or tissue allograft.
• Presence or history of immunodeficiency that requires chronic use of systemic corticosteroids (≥ 10mg of prednisone equivalent per day) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
• 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
• Major surgery within the past 4 weeks (the surgical incision should be fully healed before study drug administration).
• Any anticancer therapy within the past 2 weeks before enrollment.
• Extended field radiation within the past 4 weeks or limited field radiation within the past 2 weeks before enrollment.
• Participant s who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia and platinuminduced peripheral neuropathy.
• Participants who are receiving any other investigational agents.
• History of intestinal disease or major gastric surgery likely to alter absorption of study treatment (to be determined by the treating physician)
• Active brain metastases, unless adequately treated and participant is neurologically stable (except for residual symptoms of central nervous system treatment) for at least 2 weeks prior to enrollment without corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
• Participants with symptomatic leptomeningeal disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BMS-986340, nivolumab, or any other immune checkpoint inhibitors, TAS- 102, bevacizumab or any of its ingredients, including polysorbate 80-containing infusion.
• Has hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption
• In the investigator's opinion, uncontrolled diabetes mellitus even under treatment.
• In the investigator's opinion, uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association (NYHA) classification III or IV, arterial hypertension or uncontrolled or symptomatic arrhythmia
• Deep vein thrombosis within 4 weeks prior to randomization
• Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to enrollment.
• Severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
• Participants with uncontrolled intercurrent illness (Indicate clearly what type or extent)
• Participants with psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because BMS-986340] is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BMS-986340, breastfeeding should be discontinued if the mother is treated with BMS-986340. These potential risks may also apply to other agents used in this study.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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