NCT07492680 · Bristol-Myers Squibb
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)
What this study is about
This is an where both patients and doctors know the treatment given, conducted at multiple hospitals Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a treatment given alone component and a combination component in which BMS-986504 is given with other anti-cancer agents.
View original scientific description
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.
Interventions
DRUG
BMS-986504
Specified dose on specified days
DRUG
Daraxonrasib
Specified dose on specified days
DRUG
Nivolumab + Relatlimab FDC
Specified dose on specified days
DRUG
Temozolomide
Specified dose on specified days
DRUG
Pumitamig
Specified dose on specified days
DRUG
Pemetrexed
Specified dose on specified days
DRUG
Carboplatin
Specified dose on specified days
DRUG
Nab-paclitaxel
Specified dose on specified days
DRUG
Gemcitabine
Specified dose on specified days
DRUG
Paclitaxel
Specified dose on specified days
Primary outcome measures
Part 1: Number of participants who achieve Objective Response (OR)
Time frame: 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) 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
Part 2: Number of participants with treatment related AEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Time frame: Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Time frame: Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Time frame: Up to approximately 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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) performance status of 0 or 1.
Exclusion criteria
- 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.
- Other protocol defined inclusion/exclusion criteria applies.
Where
- San Francisco, California
- Aurora, Colorado
- Atlanta, Georgia
- Baltimore, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Rochester, Minnesota
- Buffalo, New York
- New York, New York
- Durham, North Carolina
- Houston, Texas
- Seattle, Washington
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations