Trial Details

A Randomized, Phase 2/3 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 Harboring Homozygous MTAP Deletion

NCT07076121

RECRUITING

DESCRIPTION

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

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.