A Randomized, Phase 2/3 Study Comparing Navlimetostat (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 Harboring Homozygous MTAP Deletion
A Randomized, Phase 2/3 Study Comparing Navlimetostat (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 Harboring Homozygous MTAP Deletion
The purpose of this study is to assess the safety and efficacy of Navlimetostat (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.
Inclusion Criteria:
Exclusion Criteria:
Marietta, Georgia 30060, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires 1280, Argentina
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ, Argentina
ABB, Buenos Aires F.D. C1199ABB, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Buenos Aires, 1431, Argentina
Salvador, Estado de Bahia 41253-190, Brazil
Wuhan, Hubei 430022, China
Nanjing, Jiangsu 210000, China
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Ramat Gan, Central District 5265601, Israel
Meldola, Emilia-Romagna 47014, Italy
Rome, Lazio 00168, Italy
Chuo-ku, Tokyo 104-0045, Japan
Koto, Tokyo 135-8550, Japan
Lembah Pantai, Kuala Lumpur 59100, Malaysia
Cuauhtémoc, Ciudad de México, Mexico City 06100, Mexico
Gdask, Pomeranian Voivodeship 80-952, Poland
Cluj-Napoca, Cluj 400162, Romania
Florești, Cluj 407280, Romania
Stanbul, Istanbul 34214, Turkey (Türkiye)