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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)
470 patients around the world
Available in Spain, Colombia, Chile, Brazil, Argentina, United States, Mexico, Belgium
Bristol-Myers Squibb
3Research sites
470Patients around the world
This study is for people with
Pancreatic cancer
Pancreatic ductal adenocarcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Clínica Mayo de UMCB SRL - Tucumán
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
StudyMountainTAP-30
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Pancreatic ductal adenocarcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07076121
