Status:
RECRUITING
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)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 3 2029
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT07076121
Start Date
October 23 2025
End Date
May 3 2029
Last Update
March 4 2026
Active Locations (277)
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1
Local Institution - 0142
Phoenix, Arizona, United States, 85054
2
Local Institution - 0365
Tucson, Arizona, United States, 85724
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
4
Local Institution - 0373
La Jolla, California, United States, 92037