MountainTAP-30 is a randomized, multicenter Phase 2/3 trial evaluating BMS-986504, a selective MTA-cooperative PRMT5 inhibitor, in combination with nab-paclitaxel and gemcitabine in metastatic pancreatic ductal adenocarcinoma (PDAC) harboring homozygous MTAP deletion. The study aims to assess the efficacy and safety of BMS-986504 plus nab-paclitaxel/gemcitabine compared with placebo plus nab-paclitaxel/gemcitabine. Eligible participants are adults with histologically or cytologically confirmed metastatic PDAC, documented MTAP loss in tumor tissue, and no prior systemic therapy in the metastatic setting, with at least one measurable lesion according to RECIST v1.1. MTAP status is determined in tumor tissue prior to enrollment. Participants are randomized to receive BMS-986504 or placebo in addition to standard chemotherapy. Primary endpoints include progression-free survival (PFS) per RECIST v1.1 and overall survival (OS), with key secondary endpoints including objective response rate, duration of response, time to response, and disease control rate.
MountainTAP-30 is an international Phase 2/3 clinical trial for people with metastatic pancreatic ductal adenocarcinoma. The study investigates the drug BMS-986504 in combination with the standard chemotherapy regimen nab-paclitaxel and gemcitabine. Adults whose tumors have a specific genetic change called a homozygous MTAP deletion and who have not yet received systemic treatment for metastatic disease may participate. The aim of the study is to evaluate whether adding BMS-986504 can improve the effectiveness of the standard chemotherapy. Participants are randomly assigned to receive either BMS-986504 plus chemotherapy or a placebo plus the same chemotherapy. Researchers will then assess how the disease progresses and how safe the treatment is.
