A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)

NCT07076121 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2/3

Started

2025-10-23

Last updated

2026-06-03

Condition(s) studied

Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

NavlimetostatGemcitabineNab-paclitaxelPlacebo

Navlimetostat: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Nab-paclitaxel: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC). * Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue. * Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1). * Participants must not have received any systemic anticancer treatments in the metastatic setting. * If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity. * Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization. Exclusion Criteria: * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1) — Up to 3 years after last participant is randomized
Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)
Overall Survival (OS) — Up to 3 years after last participant is randomized
Defined as the time from the randomization date to the date of death from any cause

Trial sites (269)

Facility	City	Region
Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona
Local Institution - 0365	Tucson	Arizona
Highlands Oncology Group	Springdale	Arkansas
Scripps Green Hospital	La Jolla	California
Local Institution - 0157	San Francisco	California
Baptist MD Anderson Cancer Center	Jacksonville	Florida
Mayo Clinic in Florida	Jacksonville	Florida
Winship Cancer Institute, Emory University	Atlanta	Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Marietta	Georgia
St. Luke's Cancer Institute: Boise	Boise	Idaho
Local Institution - 0168	Chicago	Illinois
Local Institution - 0125	Westwood	Kansas
Local Institution - 0370	Louisville	Kentucky
Local Institution - 0371	Baltimore	Maryland
Johns Hopkins Hospital	Baltimore	Maryland
Local Institution - 0120	Boston	Massachusetts
Brigitte Harris Cancer Pavilion	Detroit	Michigan
The Cancer & Hematology Centers	Grand Rapids	Michigan
Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota
University Of Nebraska Medical Center	Omaha	Nebraska
Roswell Park Cancer Institute	Buffalo	New York
Northwell Health/ RJ Zuckerberg Cancer Center	Lake Success	New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone	Mineola	New York
NYU Winthrop Hospital	Mineola	New York
Icahn School of Medicine at Mount Sinai	New York	New York
Local Institution - 0279	New York	New York
Wilmot Cancer Institute	Rochester	New York
University of North Carolina Medical Center	Chapel Hill	North Carolina
Local Institution - 0376	Columbus	Ohio
Kaiser Permanente Center for Health Research	Portland	Oregon
Local Institution - 0162	Portland	Oregon
St. Luke's University Health Network	Bethlehem	Pennsylvania
Local Institution - 0301	Lancaster	Pennsylvania
Thomas Jefferson University - Medical Oncology	Philadelphia	Pennsylvania
Local Institution - 0368	Pittsburgh	Pennsylvania
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
SCRI Oncology Partners	Nashville	Tennessee
Tennessee Oncology, PLLC	Smyrna	Tennessee
Texas Oncology - DFW	Dallas	Texas
Uus Oncology	Fort Worth	Texas

+ 229 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07076121 on ClinicalTrials.gov ↗ ← All trials in the UK