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
Bristol-Myers Squibb
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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/Ge…
Interventions
- DrugBMS-986504
Specified dose on specified days
- DrugGemcitabine
Specified dose on specified days
- DrugNab-paclitaxel
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (279)
- Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
- Local Institution - 0365Tucson, Arizona
- Highlands Oncology GroupSpringdale, Arkansas
- Scripps Green HospitalLa Jolla, California
- Local Institution - 0157San Francisco, California
- Baptist MD Anderson Cancer CenterJacksonville, Florida