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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Temozolomide; Drug: Nab-paclitaxel; Drug: BMS-986504; Drug: Pumitamig; Drug: Daraxonrasib; Drug: Nivolumab + Relatlimab FDC

Detailed Description

Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Local Institution - 0114
      • Contact: Site 0114
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V2S 0C2
      • Local Institution - 0051
      • Contact: Site 0051
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0007
      • Contact: Site 0007
    • Toronto, Ontario, Canada, M4N 3M5
      • Local Institution - 0021
      • Contact: Site 0021
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100071
      • Local Institution - 0155
      • Contact: Site 0155
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Local Institution - 0185
      • Contact: Site 0185
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Local Institution - 0184
      • Contact: Site 0184
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Local Institution - 0153
      • Contact: Site 0153
    • Shanghai, Shanghai Municipality, China, 200131
      • Local Institution - 0156
      • Contact: Site 0156
• France
  • Paris, France, 75010
    • Local Institution - 0074
    • Contact: Site 0074
  • Côte-d'Or
    • Dijon, Côte-d'Or, France, 21079
      • Local Institution - 0078
      • Contact: Site 0078
  • Rhône
    • Pierre-Bénite, Rhône, France, 69310
      • Local Institution - 0075
      • Contact: Site 0075
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94800
      • Local Institution - 0116
      • Contact: Site 0116
• Germany
  • Hamburg, Germany, 20246
    • Local Institution - 0040
    • Contact: Site 0040
  • Heidelberg, Germany, 69120
    • Local Institution - 0039
    • Contact: Site 0039
  • Leipzig, Germany, 04103
    • Local Institution - 0061
    • Contact: Site 0061
  • München, Germany, 81675
    • Local Institution - 0049
    • Contact: Site 0049
  • Würzburg, Germany, 97080
    • Local Institution - 0047
    • Contact: Site 0047
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Local Institution - 0081
      • Contact: Site 0081
• Hong Kong
  • Hksar, Hong Kong, 999077
    • Local Institution - 0150
    • Contact: Site 0150
  • Shatin, Hong Kong, NT
    • Local Institution - 0063
    • Contact: Site 0063
• Ireland
  • Cork, Ireland, T12 E8YV
    • Local Institution - 0080
    • Contact: Site 0080
  • Dublin, Ireland, 7
    • Local Institution - 0023
    • Contact: Site 0023
  • Dublin, Ireland, D08 E9P6
    • Local Institution - 0146
    • Contact: Site 0146
• Italy
  • Bergamo, Italy, 24127
    • Local Institution - 0123
    • Contact: Site 0123
  • Milan, Italy, 20133
    • Local Institution - 0034
    • Contact: Site 0034
  • Naples, Italy, 80131
    • Local Institution - 0050
    • Contact: Site 0050
  • Perugia, Italy, 06156
    • Local Institution - 0082
    • Contact: Site 0082
  • Tuscany
    • Siena, Tuscany, Italy, 53100
      • Local Institution - 0073
      • Contact: Site 0073
• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • Local Institution - 0020
      • Contact: Site 0020
• Norway
  • Oslo, Norway, 0450
    • Local Institution - 0022
    • Contact: Site 0022
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Local Institution - 0171
      • Contact: Site 0171
• South Korea
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
      • Local Institution - 0004
      • Contact: Site 0004
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
      • Local Institution - 0058
      • Contact: Site 0058
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
      • Local Institution - 0052
      • Contact: Site 0052
• Spain
  • Madrid, Spain, 28028
    • Local Institution - 0033
    • Contact: Site 0033
  • Seville, Spain, 41013
    • Local Institution - 0069
    • Contact: Site 0069
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Local Institution - 0068
      • Contact: Site 0068
    • Hospitalet, Barcelona [Barcelona], Spain, 08907
      • Local Institution - 0071
      • Contact: Site 0071
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Local Institution - 0059
• United States
  • California
    • San Francisco, California, United States, 94158
      • Local Institution - 0096
      • Contact: Site 0096
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Local Institution - 0182
      • Contact: Site 0182
  • Florida
    • Tampa, Florida, United States, 33612
      • Local Institution - 0122
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Local Institution - 0178
      • Contact: Site 0178
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Local Institution - 0106
      • Contact: Site 0106
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Local Institution - 0143
      • Contact: Site 0143
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0124
      • Contact: Site 0124
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0922
      • Local Institution - 0119
      • Contact: Site 0119
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 0129
      • Contact: Site 0129
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 0174
      • Contact: Site 0174
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 0181
      • Contact: Site 0181
  • New York
    • Buffalo, New York, United States, 14263
      • Local Institution - 0142
      • Contact: Site 0142
    • New York, New York, United States, 10016
      • Local Institution - 0170
      • Contact: Site 0170
    • New York, New York, United States, 10065
      • Local Institution - 0139
      • Contact: Site 0139
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Local Institution - 0100
      • Contact: Site 0100
  • Texas
    • Houston, Texas, United States, 77030
      • Local Institution - 0085
      • Contact: Site 0085
  • Washington
    • Seattle, Washington, United States, 98109
      • Local Institution - 0086
      • Contact: Site 0086
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Local Institution - 0134
      • Contact: Site 0134

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 2: Cohort 1; BMS-986504 + Pumitamig + Chemotherapy	Drug: Carboplatin; Specified dose on specified days; Drug: Paclitaxel; Specified dose on specified days; Drug: Pemetrexed; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days; Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat; Drug: Pumitamig; Specified dose on specified days; Other Names: BNT327
Experimental: Part 2: Cohort 3; BMS-986504 + Nivolumab + Relatlimab FDC	Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat; Drug: Nivolumab + Relatlimab FDC; Specified dose on specified days
Experimental: Part 2: Cohort 4; BMS-986504 + Temozolomide + Radiotherapy	Drug: Temozolomide; Specified dose on specified days; Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat
Experimental: Part 1a; BMS-986504	Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat
Experimental: Part 1b; BMS-986504	Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat
Experimental: Part 2: Cohort 2a; BMS-986504 + Daraxonrasib	Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat; Drug: Daraxonrasib; Specified dose on specified days; Other Names: RMC 6236
Experimental: Part 2: Cohort 2b; BMS-986504 + Daraxonrasib	Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat; Drug: Daraxonrasib; Specified dose on specified days; Other Names: RMC 6236
Experimental: Part 2: Cohort 2c; BMS-986504 + Daraxonrasib + Chemotherapy	Drug: Gemcitabine; Specified dose on specified days; Drug: Nab-paclitaxel; Specified dose on specified days; Drug: BMS-986504; Specified dose on specified days; Other Names: MRTX1719; Navlimetostat; Drug: Daraxonrasib; Specified dose on specified days; Other Names: RMC 6236

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of participants who achieve Objective Response (OR)	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	Up to approximately 2 years
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria		Up 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 AEs		Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs		Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation		Up to approximately 2 years
Part 2: Number of participants with AEs leading to death		Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities		Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Time to objective response (TTOR)	Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1	Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)	Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1	Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)	Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1	Up to approximately 2 years
Part 1: Number of participants with adverse events (AE)		Up to approximately 2 years
Part 1: Number of participants with Serious AEs (SAEs)		Up to approximately 2 years
Part 1: Number of participants with treatment related AEs		Up to approximately 2 years
Part 1: Number of participants with treatment related SAEs		Up to approximately 2 years
Part 1: Number of participants with AEs leading to study treatment discontinuation		Up to approximately 2 years
Part 1: Number of participants with AEs leading to death		Up to approximately 2 years
Part 1: Number of participants with laboratory abnormalities		Up to approximately 2 years
Part 2: Number of participants who achieve Objective Response (OR)		Up to approximately 2 years
Part 1 and 2: Number of participants who achieved clinical benefit (CB)	CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Estimated): July 17, 2026
• Primary Completion (Estimated): May 20, 2032
• Study Completion (Estimated): May 20, 2032

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NSCLC; GBM; Targeted therapy; Melanoma; Pancreatic cancer; Brain cancer; PRMT5; MTAP; CDKN2A; MountainTAP; Navlimetostat; Lung cancer PDAC; Navli
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Central Nervous System Neoplasms; Skin and Connective Tissue Diseases; Pancreatic Neoplasms; Melanoma; Brain Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Dacarbazine; Triazenes; Imidazoles; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Temozolomide; Nivolumab; Pemetrexed; Gemcitabine; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: CA240-0005; 2025-524285-18 (Other Identifier: EU CTR); U1111-1330-1428 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No