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Study of BMS-986504 for Advanced Solid Tumors with MTAP Deletion

This study is testing a new drug called BMS-986504, alone and in combination with other anti-cancer drugs like Daraxonrasib, Nivolumab + Relatlimab FDC, Temozolomide, and Pumitamig. It is for people aged 18 and older with advanced or metastatic (spread) solid tumors that have a specific genetic change called a homozygous MTAP deletion. To join, you must have this MTAP deletion in your tumor tissue and, depending on the group, your cancer may have progressed after previous treatments. The study aims to see how many participants respond to the treatment (tumor shrinkage or disappearance) and to check for any side effects. About 260 people are planned to join, but the current status of the study is unclear.

Study design
This is an open-label, multi-center Phase 2 study. It involves different groups, some testing BMS-986504 alone and others testing it with other anti-cancer drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 2 years to assess treatment response and side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07492680

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)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~260 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:BMS-986504DaraxonrasibNivolumab + Relatlimab FDCTemozolomidePumitamigPemetrexed

At a glance

Recruiting sites
5 of 57 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of participants who achieve Objective Response (OR)
Measured over Up to approximately 2 years
+8 more outcomes measured

Conditions

Solid Tumors

Explore related trials

GlioblastomaLung Non-Small Cell CarcinomaMelanomaPancreatic AdenocarcinomaSolid NeoplasmMTAP Gene

Where it's being run

57 sites across 37 states
Germany5
Italy4
Minnesota3
New York3
Ireland3
Seoul-teukbyeolsi [Seoul]3
Ontario2
Shanghai Municipality2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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) performance status of 0 or 1.

Exclusion

Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
Participants must not have active viral HBV or HCV hepatitis.

What this trial measures

  • Part 1: Number of participants who achieve Objective Response (OR)Up to approximately 2 years

    OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1

  • Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteriaUp to approximately 2 years
  • Part 2: Number of participants with adverse events (AE)Up to approximately 2 years
  • Part 2: Number of participants with Serious AEs (SAEs)Up to approximately 2 years
  • Part 2: Number of participants with treatment related AEsUp to approximately 2 years
  • Part 2: Number of participants with treatment related SAEsUp to approximately 2 years
  • Part 2: Number of participants with AEs leading to study treatment discontinuationUp to approximately 2 years
  • Part 2: Number of participants with AEs leading to deathUp to approximately 2 years
  • Part 2: Number of participants with laboratory abnormalitiesUp to approximately 2 years