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)

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pancreatic Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT07076121
Run by: Bristol-Myers Squibb
People needed: 470
Starts: 2025-10-23
Expected to finish: 2029-05-03
Last updated by the study team: 2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Local Institution - 0365 — Tucson, Arizona, United States
Highlands Oncology Group — Springdale, Arkansas, United States
Scripps Green Hospital — La Jolla, California, United States
Local Institution - 0157 — San Francisco, California, United States
Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Marietta, Georgia, United States
St. Luke's Cancer Institute: Boise — Boise, Idaho, United States
Local Institution - 0168 — Chicago, Illinois, United States
Local Institution - 0125 — Westwood, Kansas, United States
Local Institution - 0370 — Louisville, Kentucky, United States
Local Institution - 0371 — Baltimore, Maryland, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Local Institution - 0120 — Boston, Massachusetts, United States
Brigitte Harris Cancer Pavilion — Detroit, Michigan, United States
The Cancer & Hematology Centers — Grand Rapids, Michigan, United States
Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
University Of Nebraska Medical Center — Omaha, Nebraska, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Northwell Health/ RJ Zuckerberg Cancer Center — Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone — Mineola, New York, United States
NYU Winthrop Hospital — Mineola, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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