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A Study Comparing 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 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2026-04-30

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of 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.

Conditions

Interventions

DRUG

BMS-986504

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

DRUG

Nab-paclitaxel

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2029-05-03
Completion
2029-05-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076121 on ClinicalTrials.gov