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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)
Sponsor: Bristol-Myers Squibb
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2025-10-23
Completion Date
2029-05-03
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
BMS-986504
Specified dose on specified days
Gemcitabine
Specified dose on specified days
Nab-paclitaxel
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (279)
Local Institution - 0142
Phoenix, Arizona, United States
Local Institution - 0365
Tucson, Arizona, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Scripps Green Hospital
La Jolla, California, United States
Local Institution - 0157
San Francisco, California, United States
Local Institution - 0369
Jacksonville, Florida, United States
Local Institution - 0139
Jacksonville, Florida, United States
Local Institution - 0132
Tampa, Florida, United States
Local Institution - 0367
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, United States
Local Institution - 0168
Chicago, Illinois, United States
Local Institution - 0125
Westwood, Kansas, United States
Local Institution - 0370
Louisville, Kentucky, United States
Local Institution - 0371
Baltimore, Maryland, United States
Local Institution - 0145
Baltimore, Maryland, United States
Local Institution - 0120
Boston, Massachusetts, United States
Brigitte Harris Cancer Pavilion
Detroit, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
Local Institution - 0182
Rochester, Minnesota, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mineola, New York, United States
NYU Winthrop Hospital
Mineola, New York, United States
Local Institution - 0140
New York, New York, United States
Local Institution - 0279
New York, New York, United States
Wilmot Cancer Institute
Rochester, New York, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Local Institution - 0376
Columbus, Ohio, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Local Institution - 0162
Portland, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Local Institution - 0301
Lancaster, Pennsylvania, United States
Local Institution - 0158
Philadelphia, Pennsylvania, United States
Local Institution - 0368
Pittsburgh, Pennsylvania, United States
Local Institution - 0289
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States
Texas Oncology - DFW
Dallas, Texas, United States
Local Institution - 0374
Fort Worth, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0170
Temple, Texas, United States
Local Institution - 0344
Salt Lake City, Utah, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Local Institution - 0348
Norfolk, Virginia, United States
Local Institution - 0169
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Local Institution - 0195
Milwaukee, Wisconsin, United States
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0044
ABB, Buenos Aires F.D., Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, Argentina
Sanatorio Allende - Nueva Córdoba
Córdoba, Argentina
GenesisCare St Leonards
St Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Local Institution - 0226
Brisbane, Queensland, Australia
Local Institution - 0229
Woodville, South Australia, Australia
Cabrini Hospital - Malvern
Malvern, Victoria, Australia
Northern Hospital
Melbourne, Victoria, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Ordensklinikum Linz
Linz, Upper Austria, Austria
Uniklinikum Salzburg
Salzburg, Austria
Local Institution - 0211
Vienna, Austria
Local Institution - 0031
Bonheiden, Antwerpen, Belgium
Local Institution - 0035
Edegem, Antwerpen, Belgium
Local Institution - 0065
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0063
Brussels, Bruxelles-Capitale, Région de, Belgium
Local Institution - 0033
Ghent, Oost-Vlaanderen, Belgium
Local Institution - 0032
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0034
Liège, Belgium
Local Institution - 0102
Vitória, Espírito Santo, Brazil
Local Institution - 0291
Salvador, Estado de Bahia, Brazil
Hospital Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0074
Natal, Rio Grande do Norte, Brazil
Instituto de Oncologia Saint Gallen
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Local Institution - 0100
Rio de Janeiro, Brazil
Local Institution - 0075
São Paulo, Brazil
Local Institution - 0332
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Local Institution - 0200
Vancouver, British Columbia, Canada
Local Institution - 0202
Halifax, Nova Scotia, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Local Institution - 0156
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0048
Santiago, Santiago Metropolitan, Chile
Local Institution - 0046
Santiago, Santiago Metropolitan, Chile
Local Institution - 0047
Santiago, Santiago Metropolitan, Chile
Local Institution - 0312
Hefei, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Local Institution - 0346
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Local Institution - 0307
Chongqing, Chongqing Municipality, China
Local Institution - 0296
Fuzhou, Fujian, China
Local Institution - 0297
Fuzhou, Fujian, China
Local Institution - 0352
Guangzhou, Guangdong, China
Local Institution - 0313
Guangzhou, Guangdong, China
Local Institution - 0302
Harbin, Heilongjiang, China
Local Institution - 0295
Luoyang, Henan, China
Local Institution - 0353
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Local Institution - 0298
Wuhan, Hubei, China
Local Institution - 0293
Changsha, Hunan, China
Local Institution - 0354
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Local Institution - 0311
Nanjing, Jiangsu, China
Local Institution - 0304
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Local Institution - 0334
Jining, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Local Institution - 0355
Shanghai, Shanghai Municipality, China
Local Institution - 0300
Shanghai, Shanghai Municipality, China
Local Institution - 0239
Shanghai Shi, Shanghai Municipality, China
Local Institution - 0351
Taiyuan, Shanxi, China
Sichuan Cancer hospital
Chengdu, Sichuan, China
Local Institution - 0305
Chengdu, Sichuan, China
Tianjin Tumor Hospital
Tianjin, Tianjin Municipality, China
Local Institution - 0356
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Local Institution - 0267
Medellín, Antioquia, Colombia
Local Institution - 0338
Rionegro, Antioquia, Colombia
Local Institution - 0362
Rionegro, Antioquia, Colombia
Local Institution - 0269
Montería, Departamento de Córdoba, Colombia
Local Institution - 0268
Pereira, Risaralda Department, Colombia
Local Institution - 0266
Bogotá, Colombia
Masarykuv onkologicky ustav
Brno, Brno-město, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0070
Olomouc, Olomoucký kraj, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Local Institution - 0119
Prague, Praha 5, Czechia
Local Institution - 0130
Prague, Czechia
Herlev and Gentofte Hospital
Copenhagen, Capital Region, Denmark
Local Institution - 0116
Aarhus, Central Jutland, Denmark
Local Institution - 0021
Aalborg, North Denmark, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Local Institution - 0067
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Auvergne, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
Chu Jean Minjoz
Besançon, Doubs, France
CHU Rangueil
Toulouse, Haute-Garonne, France
Institut Curie - site Saint-Cloud
Saint-Cloud, Hauts-de-Seine, France
Local Institution - 0029
Montpellier, Hérault, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, France
Hôpital Européen Georges Pompidou
Paris, France
Hôpital Universitaire Paul Brousse
Villejuif, France
Local Institution - 0242
München, Bavaria, Germany
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen, Lower Saxony, Germany
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, North Rhine-Westphalia, Germany
Klinikum Chemnitz - Flemmingstraße
Chemnitz, Saxony, Germany
Technische Universitaet Dresden
Dresden, Saxony, Germany
DRK Kliniken Berlin - Köpenick
Berlin, Germany
Universitaetsklinikum Koeln
Cologne, Germany
Facharztzentrum Eppendorf
Hamburg, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Athens Medical Center - Psychikon branch
Athens, Attikí (Region), Greece
Aretaieio Hospital
Athens, Attikí (Region), Greece
Alexandra General Hospital of Athens
Athens, Attikí, Greece
University General Hospital of Heraklion
Heraklion, Irakleío, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Thessaloníki, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Local Institution - 0270
Shatin, Hong Kong
Local Institution - 0188
Kochi, Kerala, India
Local Institution - 0152
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0179
Bhubaneswar, Odisha, India
Local Institution - 0190
Hyderabad, Telangana, India
Local Institution - 0147
Hyderabad, Telangana, India
Local Institution - 0154
Varanasi, Uttar Pradesh, India
Local Institution - 0153
Kolkata, West Bengal, India
St. Vincent's University Hospital
Dublin, Ireland
Local Institution - 0078
Ramat Gan, Central District, Israel
Local Institution - 0080
Ẕerifin, Central District, Israel
Local Institution - 0097
Jerusalem, Jerusalem, Israel
Local Institution - 0077
Afula, Northern District, Israel
Local Institution - 0076
Tel Aviv, Tell Abīb, Israel
Local Institution - 0081
Petah Tikva, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Istituto Oncologico Veneto IRCCS
Padova, Veneto, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, Italy
Local Institution - 0222
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Local Institution - 0219
Sapporo, Hokkaido, Japan
Local Institution - 0218
Yokohama, Kanagawa, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Local Institution - 0221
Osaka, Japan
Local Institution - 0258
Kuala Lumpur, Kuala Lumpur, Malaysia
Local Institution - 0256
Lembah Pantai, Kuala Lumpur, Malaysia
Local Institution - 0257
Kuching, Sarawak, Malaysia
Local Institution - 0364
Zapopan, Jalisco, Mexico
Local Institution - 0261
Cuauhtémoc, Ciudad de México, Mexico City, Mexico
Local Institution - 0260
Mexico City, Mexico City, Mexico
Local Institution - 0264
Monterrey, Nuevo León, Mexico
Local Institution - 0265
Oaxaca City, Oaxaca, Mexico
Local Institution - 0372
Mérida, Yucatán, Mexico
Local Institution - 0263
Mexico City, Mexico
Local Institution - 0262
Puebla City, Mexico
Local Institution - 0281
Querétaro, Mexico
Local Institution - 0038
Maastricht, Limburg, Netherlands
Local Institution - 0039
Breda, North Brabant, Netherlands
Local Institution - 0277
Leiden, South Holland, Netherlands
Local Institution - 0037
Rotterdam, South Holland, Netherlands
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, Masovian Voivodeship, Poland
COPERNICUS PL, Wojewodzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0251
Gdask, Pomeranian Voivodeship, Poland
Local Institution - 0379
Warsaw, Poland
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Fundeni Clinical Institute
Bucharest, Romania
Spitalul Clinic Colțea
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Institutul Regional de Oncologie
Iași, Romania
Spitalul Municipal Schuller Ploiești
Ploieşti, Romania
National Cancer Centre Singapore
Singapore, Central Singapore, Singapore
National University Hospital
Singapore, Singapore
Local Institution - 0252
Singapore, Singapore
Local Institution - 0253
Singapore, Singapore
Local Institution - 0273
Košice, Košice Region, Slovakia
Local Institution - 0274
Trenčín, Trenčín Region, Slovakia
Local Institution - 0272
Banská Bystrica, Slovakia
Local Institution - 0275
Bratislava, Slovakia
Local Institution - 0246
Johannesburg, Gauteng, South Africa
Local Institution - 0241
Pretoria, Gauteng, South Africa
Local Institution - 0240
Soweto, Gauteng, South Africa
Local Institution - 0335
Cape Town, Western Cape, South Africa
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Skånes Universitetssjukhus Lund
Lund, Skåne Län [se-12], Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, Stockholms Län [se-01], Sweden
Akademiska sjukhuset
Uppsala, Uppsala Län [se-03], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], Sweden
Inselspital Bern
Bern, Canton of Bern, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland
Université de Genève
Geneva, Switzerland
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, Taiwan
Local Institution - 0284
Stanbul, Istanbul, Turkey (Türkiye)
Local Institution - 0283
Adana, Turkey (Türkiye)
Local Institution - 0286
Ankara, Turkey (Türkiye)
Local Institution - 0287
Ankara, Turkey (Türkiye)
Local Institution - 0285
Istanbul, Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
Royal Free Hospital
London, England, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, London, City of, United Kingdom
Sarah Cannon Research Institute UK
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton)
London, Sutton, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom