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Phase II/IIIInterventional

A Randomized, Phase 2/3 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 Harboring Homozygous MTAP Deletion

Protocol: 2025P013799NCT: NCT07076121

Overview

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

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

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.
Investigators
Locations
Emory University Hospital Midtown
Emory Saint Joseph's Hospital
Winship Cancer Institute
View on ClinicalTrials.gov