Clinical Trial Details
Back to clinical trials
View on ClinicalTrials.gov
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
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, 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
