CA240-0030:A Study of BMS-986504 in Combination with Nab-p/Gem versus Placebo in Combination with Nab-p/Gem in Untreated Metastatic PDAC with Homozygous MTAP Deletion

CA2400030 is a randomized Phase 2/3 study of BMS-986504 in combination with nab-p/gem versus placebo in combination with nab-p/gem, in participants with untreated metastatic PDAC with homozygous MTAP deletion.  

To evaluate PFS of BMS986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion. To assess the OS of BMS986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion. To evaluate the efficacy of BMS-986504 in combination with nab-p/gem vs placebo + nab-p/gem in participants with untreated metastatic PDAC with homozygous MTAP deletion.

8081 Innovation Park Drive
Fairfax, VA 22031

• Inclusion of participants with adequate hepatic function as demonstrated by laboratory values at screening such as AST/ALT and total bilirubin
• Histologically or cytologically confirmed diagnosis of metastatic PDAC
• Evidence of homozygous MTAP deletion or MTAP loss detected in tumor tissue
• Metastatic disease with at least 1 measurable lesion as per RECIST v1.1
• Recovery from the adverse effects of prior treatment (including initial cycle of nab-p/gem prior to randomization if administered) at the time of randomization to baseline or Grade ≤ 1 (excluding neuropathy, which should be Grade ≤ 2, and parameters by other eligibility [eg, hematology parameters])
• Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF

• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening
• Symptomatic brain metastases
• Known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing
• Prior organ allograft
• Any major surgery within 4 weeks prior to the first dose of study intervention. Participants must have recovered from the effects of major surgery or significant traumatic injury before the first dose of study intervention
• History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies