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Suspended
NCT07011550
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
Conditions: Microsatellite-stable Colorectal Cancer, Standard of Care, Nivolumab, Bevacizumab
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 7
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.
Eligibility Criteria
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 \ 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.
Source: ClinicalTrials.gov (NCT07011550). StuddyBuddy aggregates publicly available trial information.