Clinical Trial

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)

Active, Not Recruiting Phase 2/3
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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.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-04
notable Trial sites reduced: 279 -> 269 locations 2026-06-04
Trial Details
NCT Number NCT07076121
Lead Sponsor Bristol-Myers Squibb
Conditions Pancreatic Ductal Adenocarcinoma
Enrollment 470 participants
Start Date 2025-10-23
Primary Completion 2029-05-03 (estimated)
Study Completion 2029-05-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-03