RecruitingPhase 2Phase 3NCT07076121

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)

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

Sponsor

Bristol-Myers Squibb

Enrollment

470 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria1

Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.

Interventions

DRUGBMS-986504

Specified dose on specified days

DRUGGemcitabine

Specified dose on specified days

DRUGNab-paclitaxel

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Locations(277)

Local Institution - 0142

Phoenix, Arizona, United States

Local Institution - 0365

Tucson, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Local Institution - 0373

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

Local Institution - 0191

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

NYU Winthrop Hospital

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Local Institution - 0140

New York, New York, United States

Local Institution - 0279

New York, New York, United States

Local Institution - 0161

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

Local Institution - 0167

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - DFW

Dallas, 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

Local Institution - 0159

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 North Shore

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

Local Institution - 0101

Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0074

Natal, Rio Grande do Norte, Brazil

Local Institution - 0104

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Local Institution - 0071

Barretos, São Paulo, Brazil

Local Institution - 0100

Rio de Janeiro, Brazil

Local Institution - 0075

São Paulo, Brazil

Local Institution - 0332

São Paulo, Brazil

Local Institution - 0199

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

Local Institution - 0331

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

Local Institution - 0357

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

Local Institution - 0345

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

Local Institution - 0057

Brno, Brno-město, Czechia

Local Institution - 0060

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

Local Institution - 0062

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

Local Institution - 0224

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

Local Institution - 0086

Athens, Attikí (Region), Greece

Local Institution - 0084

Athens, Attikí, Greece

University General Hospital of Heraklion

Heraklion, Irakleío, Greece

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece

Local Institution - 0082

Thessaloniki, Thessaloníki, Greece

Local Institution - 0083

Larissa, Thessalía, Greece

Local Institution - 0271

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

Local Institution - 0225

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

Padua, Veneto, Italy

Ospedale San Raffaele

Milan, Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

Verona, Italy

Local Institution - 0222

Nagoya, Aichi-ken, Japan

Local Institution - 0217

Kashiwa, Chiba, Japan

Local Institution - 0219

Sapporo, Hokkaido, Japan

Local Institution - 0218

Yokohama, Kanagawa, Japan

Local Institution - 0216

Chuo-ku, Tokyo, Japan

Local Institution - 0220

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 - 0281

Querétaro City, Querétaro, Mexico

Local Institution - 0372

Mérida, Yucatán, Mexico

Local Institution - 0263

Mexico City, Mexico

Local Institution - 0262

Puebla City, 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

Local Institution - 0280

Warsaw, Masovian Voivodeship, Poland

COPERNICUS PL, Wojewodzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0251

Gdask, Pomeranian Voivodeship, Poland

Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, Cluj, Romania

Local Institution - 0111

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Fundeni Clinical Institute

Bucharest, Romania

Local Institution - 0109

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

Local Institution - 0255

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

Local Institution - 0014

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

Local Institution - 0016

London, Sutton, United Kingdom

The Royal Marsden Hospital

London, United Kingdom

Local Institution - 0235

Metropolitan Borough of Wirral, United Kingdom

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NCT07076121

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Conditions

Summary

Eligibility

Inclusion Criteria6

Exclusion Criteria1

Interventions

Locations(277)

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