A Randomized, Phase 2/3 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 Harboring Homozygous MTAP Deletion
Status: Recruiting
Location: See all (273) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Local Institution - 0142
NOT_YET_RECRUITING
Phoenix
Local Institution - 0365
NOT_YET_RECRUITING
Tucson
California
Scripps Green Hospital
RECRUITING
La Jolla
Local Institution - 0157
NOT_YET_RECRUITING
San Francisco
Florida
Local Institution - 0139
NOT_YET_RECRUITING
Jacksonville
Local Institution - 0369
NOT_YET_RECRUITING
Jacksonville
Local Institution - 0132
WITHDRAWN
Tampa
Georgia
Local Institution - 0367
NOT_YET_RECRUITING
Atlanta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING
Marietta
Idaho
St. Luke's Cancer Institute: Boise
RECRUITING
Boise
Illinois
Local Institution - 0168
NOT_YET_RECRUITING
Chicago
Kansas
Local Institution - 0125
NOT_YET_RECRUITING
Westwood
Kentucky
Local Institution - 0370
NOT_YET_RECRUITING
Louisville
Massachusetts
Local Institution - 0120
NOT_YET_RECRUITING
Boston
Maryland
Local Institution - 0145
NOT_YET_RECRUITING
Baltimore
Local Institution - 0371
NOT_YET_RECRUITING
Baltimore
Michigan
Brigitte Harris Cancer Pavilion
RECRUITING
Detroit
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
Minnesota
Local Institution - 0182
NOT_YET_RECRUITING
Rochester
North Carolina
University of North Carolina Medical Center
RECRUITING
Chapel Hill
Nebraska
University Of Nebraska Medical Center
RECRUITING
Omaha
New York
Roswell Park Cancer Institute
RECRUITING
Buffalo
Northwell Health/ RJ Zuckerberg Cancer Center
RECRUITING
Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
Mineola
NYU Winthrop Hospital
RECRUITING
Mineola
Local Institution - 0140
NOT_YET_RECRUITING
New York
Local Institution - 0279
NOT_YET_RECRUITING
New York
Wilmot Cancer Institute
RECRUITING
Rochester
Ohio
Local Institution - 0376
NOT_YET_RECRUITING
Columbus
Oregon
Kaiser Permanente Center for Health Research
RECRUITING
Portland
Local Institution - 0162
NOT_YET_RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Local Institution - 0301
NOT_YET_RECRUITING
Lancaster
Local Institution - 0158
NOT_YET_RECRUITING
Philadelphia
Local Institution - 0289
NOT_YET_RECRUITING
Pittsburgh
Local Institution - 0368
NOT_YET_RECRUITING
Pittsburgh
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology, PLLC
RECRUITING
Smyrna
Texas
Texas Oncology - DFW
RECRUITING
Dallas
Local Institution - 0374
NOT_YET_RECRUITING
Fort Worth
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Local Institution - 0170
NOT_YET_RECRUITING
Temple
Utah
Local Institution - 0344
NOT_YET_RECRUITING
Salt Lake City
Virginia
Inova Schar Cancer Institute
RECRUITING
Fairfax
Local Institution - 0348
NOT_YET_RECRUITING
Norfolk
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Local Institution - 0169
NOT_YET_RECRUITING
Seattle
Wisconsin
Local Institution - 0195
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
Local Institution - 0044
NOT_YET_RECRUITING
Abb
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC)
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto Alexander Fleming
RECRUITING
Ciudad Autónoma De Buenos Aires
Sanatorio Allende - Nueva Córdoba
RECRUITING
Córdoba
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Australia
Local Institution - 0226
NOT_YET_RECRUITING
Brisbane
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Cabrini Hospital - Malvern
RECRUITING
Malvern
Northern Hospital
RECRUITING
Melbourne
St. John of God Murdoch Hospital
RECRUITING
Murdoch
GenesisCare St Leonards
RECRUITING
St Leonards
Local Institution - 0229
NOT_YET_RECRUITING
Woodville
Austria
Ordensklinikum Linz
RECRUITING
Linz
Uniklinikum Salzburg
RECRUITING
Salzburg
Local Institution - 0211
NOT_YET_RECRUITING
Vienna
Belgium
Local Institution - 0031
NOT_YET_RECRUITING
Bonheiden
Local Institution - 0063
NOT_YET_RECRUITING
Brussels
Local Institution - 0065
NOT_YET_RECRUITING
Brussels
Local Institution - 0035
NOT_YET_RECRUITING
Edegem
Local Institution - 0033
NOT_YET_RECRUITING
Ghent
Local Institution - 0032
NOT_YET_RECRUITING
Leuven
Local Institution - 0034
NOT_YET_RECRUITING
Liège
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
RECRUITING
Barretos
Hospital Mario Penna
RECRUITING
Belo Horizonte
Local Institution - 0074
NOT_YET_RECRUITING
Natal
Local Institution - 0100
NOT_YET_RECRUITING
Rio De Janeiro
Local Institution - 0291
NOT_YET_RECRUITING
Salvador
Instituto de Oncologia Saint Gallen
RECRUITING
Santa Cruz Do Sul
Local Institution - 0075
NOT_YET_RECRUITING
São Paulo
Local Institution - 0332
NOT_YET_RECRUITING
São Paulo
Local Institution - 0102
NOT_YET_RECRUITING
Vitória
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
Local Institution - 0202
NOT_YET_RECRUITING
Halifax
Jewish General Hospital
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
Local Institution - 0200
NOT_YET_RECRUITING
Vancouver
Chile
Local Institution - 0046
NOT_YET_RECRUITING
Santiago
Local Institution - 0047
NOT_YET_RECRUITING
Santiago
Local Institution - 0048
NOT_YET_RECRUITING
Santiago
Local Institution - 0156
WITHDRAWN
Viña Del Mar
China
Local Institution - 0346
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Local Institution - 0293
NOT_YET_RECRUITING
Changsha
Local Institution - 0354
NOT_YET_RECRUITING
Changzhou
Local Institution - 0305
NOT_YET_RECRUITING
Chengdu
Sichuan Cancer hospital
RECRUITING
Chengdu
Local Institution - 0307
NOT_YET_RECRUITING
Chongqing
Local Institution - 0296
WITHDRAWN
Fuzhou
Local Institution - 0297
NOT_YET_RECRUITING
Fuzhou
Local Institution - 0313
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0352
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0356
NOT_YET_RECRUITING
Hangzhou
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Local Institution - 0302
NOT_YET_RECRUITING
Harbin
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Local Institution - 0312
NOT_YET_RECRUITING
Hefei
Shandong Cancer Hospital
RECRUITING
Jinan
Local Institution - 0334
NOT_YET_RECRUITING
Jining
Local Institution - 0295
NOT_YET_RECRUITING
Luoyang
Local Institution - 0311
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Local Institution - 0300
NOT_YET_RECRUITING
Shanghai
Local Institution - 0355
WITHDRAWN
Shanghai
Local Institution - 0239
WITHDRAWN
Shanghai Shi
Local Institution - 0304
NOT_YET_RECRUITING
Shenyang
Local Institution - 0351
NOT_YET_RECRUITING
Taiyuan
Tianjin Tumor Hospital
RECRUITING
Tianjin
Local Institution - 0298
WITHDRAWN
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Local Institution - 0353
NOT_YET_RECRUITING
Zhengzhou
Colombia
Local Institution - 0266
NOT_YET_RECRUITING
Bogotá
Local Institution - 0267
NOT_YET_RECRUITING
Medellín
Local Institution - 0269
NOT_YET_RECRUITING
Montería
Local Institution - 0268
WITHDRAWN
Pereira
Local Institution - 0338
NOT_YET_RECRUITING
Rionegro
Local Institution - 0362
WITHDRAWN
Rionegro
Denmark
Local Institution - 0021
NOT_YET_RECRUITING
Aalborg
Local Institution - 0116
WITHDRAWN
Aarhus
Herlev and Gentofte Hospital
RECRUITING
Copenhagen
Odense Universitetshospital
RECRUITING
Odense
Vejle Sygehus
RECRUITING
Vejle
France
Centre Hospitalier de la Côte Basque
RECRUITING
Bayonne
Chu Jean Minjoz
RECRUITING
Besançon
Centre Hospitalier Universitaire Estaing
RECRUITING
Clermont-ferrand
Centre Georges François Leclerc
RECRUITING
Dijon
Local Institution - 0067
NOT_YET_RECRUITING
Lyon
Institut Paoli-Calmettes
RECRUITING
Marseille
Local Institution - 0029
NOT_YET_RECRUITING
Montpellier
Hôpital Européen Georges Pompidou
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Institut Curie - site Saint-Cloud
RECRUITING
Saint-cloud
CHU Rangueil
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy
RECRUITING
Villejuif
Hôpital Universitaire Paul Brousse
RECRUITING
Villejuif
Germany
DRK Kliniken Berlin - Köpenick
RECRUITING
Berlin
St. Josef und St. Elisabeth Hospital gGmbH
RECRUITING
Bochum
Klinikum Chemnitz - Flemmingstraße
RECRUITING
Chemnitz
Universitaetsklinikum Koeln
RECRUITING
Cologne
Technische Universitaet Dresden
RECRUITING
Dresden
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt Am Main
Universitätsmedizin Göttingen - Georg-August-Universität
RECRUITING
Göttingen
Facharztzentrum Eppendorf
RECRUITING
Hamburg
Local Institution - 0242
NOT_YET_RECRUITING
München
Universitaetsklinikum Ulm
RECRUITING
Ulm
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
Aretaieio Hospital
RECRUITING
Athens
Athens Medical Center - Psychikon branch
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Larissa
RECRUITING
Larissa
Papageorgiou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Theagenio Cancer Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Local Institution - 0270
NOT_YET_RECRUITING
Shatin
India
Local Institution - 0179
NOT_YET_RECRUITING
Bhubaneswar
Local Institution - 0147
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0190
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0188
NOT_YET_RECRUITING
Kochi
Local Institution - 0153
NOT_YET_RECRUITING
Kolkata
Local Institution - 0152
NOT_YET_RECRUITING
New Delhi
Local Institution - 0154
NOT_YET_RECRUITING
Varanasi
Ireland
St. Vincent's University Hospital
RECRUITING
Dublin
Israel
Local Institution - 0077
NOT_YET_RECRUITING
Afula
Local Institution - 0097
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0081
NOT_YET_RECRUITING
Petah Tikva
Local Institution - 0078
NOT_YET_RECRUITING
Ramat Gan
Local Institution - 0076
NOT_YET_RECRUITING
Tel Aviv
Local Institution - 0080
NOT_YET_RECRUITING
Ẕerifin
Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Universitaria Federico II
RECRUITING
Naples
Istituto Oncologico Veneto IRCCS
RECRUITING
Padova
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
RECRUITING
Verona
Japan
National Cancer Center Hospital
RECRUITING
Chuo-ku
National Cancer Center Hospital East
RECRUITING
Kashiwa
The Cancer Institute Hospital of JFCR
RECRUITING
Koto
Local Institution - 0222
NOT_YET_RECRUITING
Nagoya
Local Institution - 0221
NOT_YET_RECRUITING
Osaka
Local Institution - 0219
NOT_YET_RECRUITING
Sapporo
Local Institution - 0218
NOT_YET_RECRUITING
Yokohama
Malaysia
Local Institution - 0258
NOT_YET_RECRUITING
Kuala Lumpur
Local Institution - 0257
NOT_YET_RECRUITING
Kuching
Local Institution - 0256
NOT_YET_RECRUITING
Lembah Pantai
Mexico
Local Institution - 0261
NOT_YET_RECRUITING
Cuauhtémoc, Ciudad De México
Local Institution - 0372
NOT_YET_RECRUITING
Mérida
Local Institution - 0260
NOT_YET_RECRUITING
Mexico City
Local Institution - 0263
WITHDRAWN
Mexico City
Local Institution - 0264
NOT_YET_RECRUITING
Monterrey
Local Institution - 0265
NOT_YET_RECRUITING
Oaxaca City
Local Institution - 0262
NOT_YET_RECRUITING
Puebla City
Local Institution - 0281
NOT_YET_RECRUITING
Querétaro
Local Institution - 0364
NOT_YET_RECRUITING
Zapopan
Netherlands
Local Institution - 0039
NOT_YET_RECRUITING
Breda
Local Institution - 0277
NOT_YET_RECRUITING
Leiden
Local Institution - 0038
NOT_YET_RECRUITING
Maastricht
Local Institution - 0037
NOT_YET_RECRUITING
Rotterdam
Poland
COPERNICUS PL, Wojewodzkie Centrum Onkologii
RECRUITING
Gdansk
Local Institution - 0251
NOT_YET_RECRUITING
Gdask
Centrum Medyczne Pratia Poznań
RECRUITING
Poznan
Centrum Medyczne Pratia Warszawa
RECRUITING
Warsaw
Local Institution - 0379
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Romania
Fundeni Clinical Institute
RECRUITING
Bucharest
Spitalul Clinic Colțea
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie
RECRUITING
Craiova
SC Radiotherapy Center Cluj SRL
RECRUITING
Florești
Institutul Regional de Oncologie
RECRUITING
Iași
Spitalul Municipal Schuller Ploiești
RECRUITING
Ploieşti
Singapore
Local Institution - 0252
NOT_YET_RECRUITING
Singapore
Local Institution - 0253
NOT_YET_RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Slovakia
Local Institution - 0272
NOT_YET_RECRUITING
Banská Bystrica
Local Institution - 0275
NOT_YET_RECRUITING
Bratislava
Local Institution - 0273
NOT_YET_RECRUITING
Košice
Local Institution - 0274
NOT_YET_RECRUITING
Trenčín
South Africa
Local Institution - 0335
NOT_YET_RECRUITING
Cape Town
Local Institution - 0246
NOT_YET_RECRUITING
Johannesburg
Local Institution - 0241
NOT_YET_RECRUITING
Pretoria
Local Institution - 0240
NOT_YET_RECRUITING
Soweto
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Skånes Universitetssjukhus Lund
RECRUITING
Lund
Karolinska Universitetssjukhuset Huddinge
RECRUITING
Stockholm
Akademiska sjukhuset
RECRUITING
Uppsala
Switzerland
Ospedale Regionale Bellinzona e Valli
RECRUITING
Bellinzona
Inselspital Bern
RECRUITING
Bern
Université de Genève
RECRUITING
Geneva
Cantonal Hospital St.Gallen
RECRUITING
Sankt Gallen
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Local Institution - 0283
NOT_YET_RECRUITING
Adana
Local Institution - 0286
NOT_YET_RECRUITING
Ankara
Local Institution - 0287
NOT_YET_RECRUITING
Ankara
Local Institution - 0285
NOT_YET_RECRUITING
Istanbul
Local Institution - 0284
NOT_YET_RECRUITING
Stanbul
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Royal Free Hospital
RECRUITING
London
Royal Marsden Hospital (Sutton)
RECRUITING
London
Sarah Cannon Research Institute UK
RECRUITING
London
The Royal Marsden Hospital
RECRUITING
London
The Clatterbridge Cancer Centre
RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2029-05-03
Participants
Target number of participants: 470
Treatments
Experimental: Arm A
Experimental: Arm B
Placebo_comparator: Arm C
Placebo_comparator: Arm D
Experimental: Arm E
Placebo_comparator: Arm F
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb