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)

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT07076121

This study evaluates the safety and efficacy of BMS-986504, a PRMT5 inhibitor, with nab-paclitaxel/gemcitabine in untreated metastatic PDAC with MTAP deletion. Eligible participants must have confirmed metastatic PDAC, MTAP deletion, and measurable lesions. Interventions include BMS-986504, gemcitabine, nab-paclitaxel, and placebo, administered in specified doses.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 014285054PhoenixArizona
Local Institution - 036585724TucsonArizona
Highlands Oncology Group72762SpringdaleArkansas
Local Institution - 037392037La JollaCalifornia
Local Institution - 015794115San FranciscoCalifornia
Local Institution - 013932224JacksonvilleFlorida
Local Institution - 013233612TampaFlorida
Local Institution - 036730322AtlantaGeorgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital30060MariettaGeorgia
Local Institution - 012683712BoiseIdaho

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