NCT07492680PHASE2NOT_YET_RECRUITING

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

Sponsor: Bristol-Myers Squibb

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Solid Tumors

Interventions

BMS-986504, Daraxonrasib, Nivolumab + Relatlimab FDC, Temozolomide

Enrollment

260 participants

Primary completion

May 2032

Study completion

May 2032

First posted

Mar 2026

Last updated

May 2026

Primary Endpoints (CT.gov)

Part 1: Number of participants who achieve Objective Response (OR)

Time frame: Up to approximately 2 years

Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria

Time frame: Up to approximately 2 years

Part 2: Number of participants with adverse events (AE)

Time frame: Up to approximately 2 years

Part 2: Number of participants with Serious AEs (SAEs)

Time frame: Up to approximately 2 years

Secondary Endpoints

Part 1 and 2: Time to objective response (TTOR)

Part 1 and 2: Duration of response (DOR)

Part 1 and 2: Number of participants who achieve disease control (DC)

Eligibility Criteria

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease. * Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline. * Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN. * Participant must have Eastern Cooperative Oncology Group (ECOG) performan…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov