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)
Фаза 2/3 – комбинирано изпитване
Заболявания:
Pancreatic Ductal Adenocarcinoma
Спонсор: Bristol-Myers Squibb
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
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EN