Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and… (NCT07011550) | Clinical Trial Compass
SuspendedPhase 2
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
Stopped: PI Request
United States7 participantsStarted 2025-08-15
Plain-language summary
To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.
Who can participate
Age range18 Years
SexALL
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Eligibility Criteria
* Participants with histologically or cytologically confirmed colorectal adenocarcinoma who have metastatic or locally advanced and unresectable disease and are microsatellite stable (MSS).
* Participants must have measurable disease as defined by RECIST version 1.1.
* Participants must be refractory or intolerant to fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab (if eligible), and cetuximab or panitumumab (if eligible).
o Regimens received in the adjuvant setting with recurrence within 6 months would be considered eligible treatments.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of BMS-986340 in combination with Nivolumab in participant s \<18 years of age, children are excluded from this study.
* ECOG performance status ≤2 (Karnofsky ≥60%,).
* Participants must have adequate organ and marrow function as defined below:
* absolute neutrophil count ≥1,500/mcL
* Hemoglobin ≥9 g/dL
* platelets ≥100,000/mcL
* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN (unless if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) ≤ 5 x ULN)
* Total serum bilirubin \<1.5 x upper limit of normal (ULN) (unless Gilbert disease confirmed)
* Creatinine ≤ institutional ULN
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants with a history of hepatitis …
What they're measuring
1
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year