This study involves people with pancreatic ductal adenocarcinoma that has spread to other parts of the body and has not been treated yet. Pancreatic ductal adenocarcinoma is a type of cancer that starts in the pancreas, an organ that helps with digestion and blood sugar control. The study specifically looks at tumors that have a particular genetic change called homozygous MTAP deletion, which means a specific gene is missing in both copies within the cancer cells. The treatments being studied include BMS-986504, which is also known as MRTX1719, along with two other cancer medicines called nab-paclitaxel and gemcitabine. Some people in the study will receive BMS-986504 combined with nab-paclitaxel and gemcitabine, while others will receive placebo combined with nab-paclitaxel and gemcitabine. BMS-986504 is given as a tablet by mouth, while nab-paclitaxel and gemcitabine are given through a vein.
The purpose of the study is to test whether BMS-986504 combined with nab-paclitaxel and gemcitabine can help people live longer and delay the time until the cancer gets worse compared to placebo combined with nab-paclitaxel and gemcitabine. The study will also look at whether the combination treatment can shrink tumors and control tumor growth. People joining the study must have their cancer confirmed through tissue samples and must have evidence of the MTAP deletion in their tumor. The cancer must have spread to other parts of the body with at least one area that can be measured on scans.
During the study, people will be randomly assigned to receive either BMS-986504 or placebo, both given together with nab-paclitaxel and gemcitabine. The study will track how long it takes for the cancer to worsen on scans and how long people survive. Researchers will also measure how much tumors shrink, how long any shrinkage lasts, and how many people experience tumor control or shrinkage. People in the study must not have received any cancer treatment for their spread disease before joining, although they may have received up to one cycle of nab-paclitaxel and gemcitabine before being assigned to a treatment group.
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