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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)
Trial Status: active
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07076121.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Approved
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Approved
Name Not Available
New York
Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Pennsylvania
Lancaster
Lancaster General Ann B Barshinger Cancer Institute
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium