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

NCT07011550 | Suspended Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0342NCI-2025-04161
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microsatellite-stable Colorectal Cancer; Standard of Care; Nivolumab; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

SLI/Exp

EXPERIMENTAL

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

Drug: Nivolumab; Drug: Bevacizumab; Drug: BMS-986340; Drug: Trifluridine + Tipiracil

Interventions

Bevacizumab DRUG

Given by IV

SLI/Exp

BMS-986340 DRUG

Given by IV

SLI/Exp

Trifluridine + Tipiracil DRUG

Given by PO

SLI/Exp

Nivolumab DRUG

Given by IV

SLI/Exp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Strategic Alliance: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Nivolumab; Bevacizumab; trifluridine tipiracil drug combination

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Madhulika Eluri, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 9, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)