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
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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0142 | 85054 | Phoenix | Arizona |
| Local Institution - 0365 | 85724 | Tucson | Arizona |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Local Institution - 0373 | 92037 | La Jolla | California |
| Local Institution - 0157 | 94115 | San Francisco | California |
| Local Institution - 0139 | 32224 | Jacksonville | Florida |
| Local Institution - 0132 | 33612 | Tampa | Florida |
| Local Institution - 0367 | 30322 | Atlanta | Georgia |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | 30060 | Marietta | Georgia |
| Local Institution - 0126 | 83712 | Boise | Idaho |
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