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)

NCT07492680 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA240-00052025-524285-18U1111-1330-1428
• Study Type: interventional
• Target: 260
• Locations: 13 countries
• Sites: 55

Brief Summary

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.

Conditions

Solid Tumors

Keywords

MTAP; CDKN2A; PRMT5; MountainTAP; Targeted therapy; Brain cancer; GBM; Melanoma; NSCLC; Lung cancer PDAC; Pancreatic cancer; Navlimetostat; Navli

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (12)

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

  Up to approximately 2 years

• Part 1 and 2: Duration of response (DOR)

  Up to approximately 2 years

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

  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

Study Arms (8)

Part 1a

EXPERIMENTAL

Drug: BMS-986504

Part 1b

EXPERIMENTAL

Drug: BMS-986504

Part 2: Cohort 1

EXPERIMENTAL

BMS-986504 + Pumitamig + Chemotherapy

Drug: BMS-986504; Drug: Pumitamig; Drug: Pemetrexed; Drug: Carboplatin; Drug: Nab-paclitaxel; Drug: Paclitaxel

Part 2: Cohort 2a

EXPERIMENTAL

BMS-986504 + Pan-RAS inhibitor

Drug: BMS-986504; Drug: Daraxonrasib

Part 2: Cohort 2b

EXPERIMENTAL

BMS-986504 + Pan-RAS inhibitor

Drug: BMS-986504; Drug: Daraxonrasib

Part 2: Cohort 2c

EXPERIMENTAL

BMS-986504 + Pan-RAS inhibitor + Chemotherapy

Drug: BMS-986504; Drug: Daraxonrasib; Drug: Nab-paclitaxel; Drug: Gemcitabine

Part 2: Cohort 3

EXPERIMENTAL

BMS-986504 + Nivolumab + Relatlimab FDC

Drug: BMS-986504; Drug: Nivolumab + Relatlimab FDC

Part 2: Cohort 4

EXPERIMENTAL

BMS-986504 + Temozolomide + Radiotherapy

Drug: BMS-986504; Drug: Temozolomide

Interventions

Daraxonrasib DRUG

Specified dose on specified days

Also known as: RMC 6236

Part 2: Cohort 2a; Part 2: Cohort 2b; Part 2: Cohort 2c

Nivolumab + Relatlimab FDC DRUG

Specified dose on specified days

Part 2: Cohort 3

Temozolomide DRUG

Specified dose on specified days

Part 2: Cohort 4

Pumitamig DRUG

Specified dose on specified days

Also known as: BNT327

Part 2: Cohort 1

Pemetrexed DRUG

Specified dose on specified days

Part 2: Cohort 1

Carboplatin DRUG

Specified dose on specified days

Part 2: Cohort 1

Nab-paclitaxel DRUG

Specified dose on specified days

Part 2: Cohort 1; Part 2: Cohort 2c

Gemcitabine DRUG

Specified dose on specified days

Part 2: Cohort 2c

Paclitaxel DRUG

Specified dose on specified days

Part 2: Cohort 1

BMS-986504 DRUG

Specified dose on specified days

Also known as: MRTX1719, Navlimetostat

Part 1a; Part 1b; Part 2: Cohort 1; Part 2: Cohort 2a; Part 2: Cohort 2b; Part 2: Cohort 2c; Part 2: Cohort 3; Part 2: Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) should be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer should be ≤ 2 × ULN.
• Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• 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 (eg, uncontrolled nausea, vomiting, malabsorption syndrome) 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (55)

Local Institution - 0096

San Francisco, California, 94158, United States

Location

Local Institution - 0182

Aurora, Colorado, 80045, United States

Location

Local Institution - 0122

Tampa, Florida, 33612, United States

Location

Local Institution - 0178

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0106

Chicago, Illinois, 60637, United States

Location

Local Institution - 0143

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0124

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0119

Ann Arbor, Michigan, 48109-0922, United States

Location

Local Institution - 0129

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0174

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0181

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0142

Buffalo, New York, 14263, United States

Location

Local Institution - 0170

New York, New York, 10016, United States

Location

Local Institution - 0139

New York, New York, 10021, United States

Location

Local Institution - 0100

Durham, North Carolina, 27705, United States

Location

Local Institution - 0085

Houston, Texas, 77030, United States

Location

Local Institution - 0086

Seattle, Washington, 98109, United States

Location

Local Institution - 0134

Madison, Wisconsin, 53792, United States

Location

Local Institution - 0114

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Local Institution - 0051

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

Location

Local Institution - 0021

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0007

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0155

Beijing, Beijing Municipality, 100071, China

Location

Local Institution - 0153

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0156

Shanghai, Shanghai Municipality, 200131, China

Location

Local Institution - 0078

Dijon, Côte-d'Or, 21079, France

Location

Local Institution - 0075

Pierre-Bénite, Rhône, 69310, France

Location

Local Institution - 0116

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0074

Paris, 75010, France

Location

Local Institution - 0081

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Local Institution - 0040

Hamburg, 20246, Germany

Location

Local Institution - 0039

Heidelberg, 69120, Germany

Location

Local Institution - 0061

Leipzig, 04103, Germany

Location

Local Institution - 0049

München, 81675, Germany

Location

Local Institution - 0047

Würzburg, 97080, Germany

Location

Local Institution - 0063

Shatin, NT, Hong Kong

Location

Local Institution - 0080

Cork, T12 E8YV, Ireland

Location

Local Institution - 0023

Dublin, 7, Ireland

Location

Local Institution - 0146

Dublin, D08 E9P6, Ireland

Location

Local Institution - 0073

Siena, Tuscany, 53100, Italy

Location

Local Institution - 0123

Bergamo, 24127, Italy

Location

Local Institution - 0034

Milan, 20133, Italy

Location

Local Institution - 0050

Naples, 80131, Italy

Location

Local Institution - 0082

Perugia, 06156, Italy

Location

Local Institution - 0020

Chuo-ku, Tokyo, 104-0045, Japan

Location

Local Institution - 0171

Bergen, Hordaland, 5021, Norway

Location

Local Institution - 0022

Oslo, 0450, Norway

Location

Local Institution - 0004

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0058

Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea

Location

Local Institution - 0052

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Local Institution - 0068

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0071

Hospitalet, Barcelona [Barcelona], 08907, Spain

Location

Local Institution - 0033

Madrid, 28028, Spain

Location

Local Institution - 0059

Madrid, 28034, Spain

Location

Local Institution - 0069

Seville, 41013, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Brain Neoplasms; Melanoma; Pancreatic Neoplasms

Interventions

Nivolumab; Temozolomide; Pemetrexed; Carboplatin; 130-nm albumin-bound paclitaxel; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 25, 2026
• Study Start (Estimated): July 17, 2026
• Primary Completion (Estimated): May 20, 2032
• Study Completion (Estimated): May 20, 2032
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

KR (3); IT (5); US (18); HK (1); JP (1); CA (3); IE (3); FR (4); NO (2); CN (3); BE (1); DE (6); ES (5)