A 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 With Homozygous MTAP Deletion (MountainTAP-30)

NCT07076121 | Active Not Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: CA240-00302025-522598-12U1111-1320-4708CA2400030
• Study Type: interventional
• Target: 470
• Locations: 35 countries
• Sites: 262

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

PRMT5; MTAP; MRTX1719; MountainTAP; Pancreatic cancer; PDAC

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)

  Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)

  Up to 3 years after last participant is randomized

• Overall Survival (OS)

  Defined as the time from the randomization date to the date of death from any cause

  Up to 3 years after last participant is randomized

Secondary Outcomes (10)

• Objective Response (OR) as assessed by RECIST v1.1

  Up to 3 years after last participant is randomized

• Duration of Response (DOR) as assessed by RECIST v1.1

  Up to 3 years after last participant is randomized

• Time to Objective Response (TTOR) as assessed by RECIST v1.1

  Up to 3 years after last participant is randomized

• Disease control as assessed by RECIST v1.1

  Up to 3 years after last participant is randomized

• Number of participants with treatment-related adverse events (TRAEs)

  Up to 28 days after the last drug administration

Study Arms (6)

Arm A

EXPERIMENTAL

Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel

Arm B

EXPERIMENTAL

Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel

Arm C

PLACEBO COMPARATOR

Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo

Arm D

PLACEBO COMPARATOR

Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo

Arm E

EXPERIMENTAL

Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel

Arm F

PLACEBO COMPARATOR

Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo

Interventions

Gemcitabine DRUG

Specified dose on specified days

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Nab-paclitaxel DRUG

Specified dose on specified days

Also known as: Abraxane

Arm A; Arm B; Arm C; Arm D; Arm E; Arm F

Placebo DRUG

Specified dose on specified days

Arm C; Arm D; Arm F

Navlimetostat DRUG

Specified dose on specified days

Also known as: BMS-986504, MRTX1719

Arm A; Arm B; Arm E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (269)

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, 85054, United States

Location

Local Institution - 0365

Tucson, Arizona, 85724, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Local Institution - 0157

San Francisco, California, 94115, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060, United States

Location

St. Luke's Cancer Institute: Boise

Boise, Idaho, 83712, United States

Location

Local Institution - 0168

Chicago, Illinois, 60637, United States

Location

Local Institution - 0125

Westwood, Kansas, 66205, United States

Location

Local Institution - 0370

Louisville, Kentucky, 40202, United States

Location

Local Institution - 0371

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Local Institution - 0120

Boston, Massachusetts, 02215, United States

Location

Brigitte Harris Cancer Pavilion

Detroit, Michigan, 48202, United States

Location

The Cancer & Hematology Centers

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, 55905, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

Location

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Mineola, New York, 11501, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Local Institution - 0279

New York, New York, 10065, United States

Location

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27514, United States

Location

Local Institution - 0376

Columbus, Ohio, 43210, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Local Institution - 0162

Portland, Oregon, 97239, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 0301

Lancaster, Pennsylvania, 17601, United States

Location

Thomas Jefferson University - Medical Oncology

Philadelphia, Pennsylvania, 19107, United States

Location

Local Institution - 0368

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Tennessee Oncology, PLLC

Smyrna, Tennessee, 37167, United States

Location

Texas Oncology - DFW

Dallas, Texas, 75246, United States

Location

Uus Oncology

Fort Worth, Texas, 76177, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution - 0170

Temple, Texas, 76508, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Local Institution - 0348

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0169

Seattle, Washington, 98101, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hospital Británico de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

Location

Instituto Alexander Fleming

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., C1199ABB, Argentina

Location

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

Buenos Aires, 1431, Argentina

Location

Sanatorio Allende - Nueva Córdoba

Córdoba, 5000, Argentina

Location

GenesisCare St Leonards

St Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Local Institution - 0226

Brisbane, Queensland, 4102, Australia

Location

Local Institution - 0229

Woodville, South Australia, 5011, Australia

Location

Cabrini Hospital - Malvern

Malvern, Victoria, 3144, Australia

Location

Northern Hospital

Melbourne, Victoria, 3076, Australia

Location

St. John of God Murdoch Hospital

Murdoch, Western Australia, 6150, Australia

Location

Ordensklinikum Linz

Linz, Upper Austria, 4010, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Imelda General Hospital

Bonheiden, Antwerpen, 2820, Belgium

Location

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

Location

Institut Jules Bordet

Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium

Location

Cliniques universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0034

Liège, 4000, Belgium

Location

CEDOES

Vitória, Espírito Santo, 29055450, Brazil

Location

Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital Mario Penna

Belo Horizonte, Minas Gerais, 30380-472, Brazil

Location

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

Instituto de Oncologia Saint Gallen

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

Location

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, 14784400, Brazil

Location

Oncoclinicas Rio de Janeiro

Rio de Janeiro, 22250-905, Brazil

Location

Icesp - Instituto Do Câncer Do Estado de São Paulo

São Paulo, 01246-000, Brazil

Location

Local Institution - 0332

São Paulo, 01401-002, Brazil

Location

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Local Institution - 0200

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0202

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

FALP

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Clínica UC San Carlos de Apoquindo

Santiago, Santiago Metropolitan, 7620002, Chile

Location

Bradfordhill

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0312

Hefei, Anhui, 230000, China

Location

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230031, China

Location

Local Institution - 0346

Beijing, Beijing Municipality, 100021, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Local Institution - 0307

Chongqing, Chongqing Municipality, 400030, China

Location

Local Institution - 0297

Fuzhou, Fujian, 350014, China

Location

Local Institution - 0352

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Local Institution - 0302

Harbin, Heilongjiang, 150081, China

Location

Local Institution - 0295

Luoyang, Henan, 471003, China

Location

Local Institution - 0353

Zhengzhou, Henan, 450000, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Local Institution - 0293

Changsha, Hunan, 421000, China

Location

Local Institution - 0354

Changzhou, Jiangsu, 213003, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0311

Nanjing, Jiangsu, 210009, China

Location

Local Institution - 0304

Shenyang, Liaoning, 110042, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Local Institution - 0334

Jining, Shandong, 272029, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0300

Shanghai, Shanghai Municipality, 200040, China

Location

Local Institution - 0351

Taiyuan, Shanxi, 030000, China

Location

Sichuan Cancer hospital

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610066, China

Location

Tianjin Tumor Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Local Institution - 0356

Hangzhou, Zhejiang, 310000, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0267

Medellín, Antioquia, 050030, Colombia

Location

Local Institution - 0338

Rionegro, Antioquia, 054047, Colombia

Location

Local Institution - 0269

Montería, Departamento de Córdoba, 230002, Colombia

Location

Local Institution - 0266

Bogotá, 110411, Colombia

Location

Masarykuv onkologicky ustav

Brno, Brno-město, 656 53, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, Olomouc Region, 779 00, Czechia

Location

Fakultni Thomayerova nemocnice

Prague, Praha 4, 14059, Czechia

Location

Fakultni nemocnice Motol a Homolka

Prague, Praha 5, 150 06, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Location

Herlev and Gentofte Hospital

Copenhagen, Capital Region, 2730, Denmark

Location

Local Institution - 0021

Aalborg, North Denmark, 9000, Denmark

Location

Odense Universitetshospital

Odense, Region Syddanmark, 5000, Denmark

Location

Vejle Sygehus

Vejle, Region Syddanmark, 7100, Denmark

Location

Local Institution - 0067

Lyon, Auvergne-Rhône-Alpes, 69003, France

Location

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, Auvergne, 63100, France

Location

Centre Georges François Leclerc

Dijon, Côte-d'Or, 21079, France

Location

Chu Jean Minjoz

Besançon, Doubs, 25000, France

Location

CHU Rangueil

Toulouse, Haute-Garonne, 31059, France

Location

Institut Curie - site Saint-Cloud

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

Local Institution - 0029

Montpellier, Hérault, 34298, France

Location

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, Pyrénées-Atlantiques, 64109, France

Location

Gustave Roussy

Villejuif, Val-de-Marne, 94800, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne, 86021, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Hôpital Universitaire Paul Brousse

Villejuif, 94800, France

Location

TUM Klinikum

München, Bavaria, 81675, Germany

Location

Krankenhaus Nordwest GmbH

Frankfurt am Main, Hesse, 60488, Germany

Location

Universitätsmedizin Göttingen - Georg-August-Universität

Göttingen, Lower Saxony, 37075, Germany

Location

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Klinikum Chemnitz - Flemmingstraße

Chemnitz, Saxony, 09116, Germany

Location

Technische Universitaet Dresden

Dresden, Saxony, 01069, Germany

Location

DRK Kliniken Berlin - Köpenick

Berlin, 12559, Germany

Location

Universitaetsklinikum Koeln

Cologne, 50937, Germany

Location

Facharztzentrum Eppendorf

Hamburg, 20249, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

Athens Medical Center - Psychikon branch

Athens, Attikí (Region), 115 25, Greece

Location

Aretaieio Hospital

Athens, Attikí (Region), 115 28, Greece

Location

Alexandra General Hospital of Athens

Athens, Attikí, 115 28, Greece

Location

University General Hospital of Heraklion

Heraklion, Irakleío, 71500, Greece

Location

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía, 540 07, Greece

Location

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, Thessaloníki, 564 29, Greece

Location

University General Hospital of Larissa

Larissa, Thessalía, 41110, Greece

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Local Institution - 0270

Shatin, NT, Hong Kong

Location

Local Institution - 0188

Kochi, Kerala, 682041, India

Location

Local Institution - 0378

Mumbai, Maharashtra, 400012, India

Location

Local Institution - 0152

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Local Institution - 0179

Bhubaneswar, Odisha, 751003, India

Location

Local Institution - 0190

Hyderabad, Telangana, 500032, India

Location

Local Institution - 0147

Hyderabad, Telangana, 500033, India

Location

Local Institution - 0154

Varanasi, Uttar Pradesh, 221005, India

Location

Local Institution - 0153

Kolkata, West Bengal, 700094, India

Location

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

Location

Local Institution - 0078

Ramat Gan, Central District, 5265601, Israel

Location

Local Institution - 0080

Ẕerifin, Central District, 70300, Israel

Location

Local Institution - 0097

Jerusalem, Jerusalem, 9112001, Israel

Location

Local Institution - 0077

Afula, Northern District, 1834111, Israel

Location

Local Institution - 0076

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Local Institution - 0081

Petah Tikva, 4941492, Israel

Location

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Lombardy, 20133, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

Location

Istituto Oncologico Veneto IRCCS

Padova, Veneto, 35128, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

Verona, 37134, Italy

Location

Local Institution - 0222

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

Local Institution - 0219

Sapporo, Hokkaido, 060-8543, Japan

Location

Kanagawa cancer center

Yokohama, Kanagawa, 2418515, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Local Institution - 0258

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

Local Institution - 0256

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Local Institution - 0257

Kuching, Sarawak, 93586, Malaysia

Location

Local Institution - 0364

Zapopan, Jalisco, 45050, Mexico

Location

Local Institution - 0261

Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico

Location

Local Institution - 0260

Mexico City, Mexico City, 03100, Mexico

Location

Local Institution - 0264

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0265

Oaxaca City, Oaxaca, 68020, Mexico

Location

Local Institution - 0372

Mérida, Yucatán, 97070, Mexico

Location

Local Institution - 0262

Puebla City, 72424, Mexico

Location

Local Institution - 0281

Querétaro, 76000, Mexico

Location

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

Location

Local Institution - 0039

Breda, North Brabant, 4818 CK, Netherlands

Location

Local Institution - 0277

Leiden, South Holland, 2333 ZA, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Centrum Medyczne Pratia Poznań

Poznan, Greater Poland Voivodeship, 60-192, Poland

Location

Centrum Medyczne Pratia Warszawa

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

COPERNICUS PL, Wojewodzkie Centrum Onkologii

Gdansk, Pomeranian Voivodeship, 80-219, Poland

Location

Local Institution - 0251

Gdask, Pomeranian Voivodeship, 80-952, Poland

Location

Local Institution - 0379

Warsaw, 02-781, Poland

Location

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

Cluj-Napoca, Cluj, 400162, Romania

Location

SC Radiotherapy Center Cluj SRL

Florești, Cluj, 407280, Romania

Location

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 200542, Romania

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

Spitalul Clinic Colțea

Bucharest, 030171, Romania

Location

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

Location

Institutul Regional de Oncologie

Iași, 700483, Romania

Location

Spitalul Municipal Schuller Ploiești

Ploieşti, 100337, Romania

Location

National Cancer Centre Singapore

Singapore, Central Singapore, 168583, Singapore

Location

National University Hospital

Singapore, 119074, Singapore

Location

Local Institution - 0252

Singapore, 308433, Singapore

Location

Local Institution - 0253

Singapore, 329563, Singapore

Location

Local Institution - 0273

Košice, Košice Region, 041 91, Slovakia

Location

Local Institution - 0274

Trenčín, Trenčín Region, 911 01, Slovakia

Location

Local Institution - 0272

Banská Bystrica, 97517, Slovakia

Location

Local Institution - 0275

Bratislava, 83101, Slovakia

Location

Local Institution - 0240

Soweto, Gauteng, 2013, South Africa

Location

Local Institution - 0335

Cape Town, Western Cape, 7937, South Africa

Location

Local Institution - 0246

Johannesburg, 2193, South Africa

Location

Local Institution - 0241

Pretoria, 0001, South Africa

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Skånes Universitetssjukhus Lund

Lund, Skåne Län [se-12], 22185, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, Stockholms Län [se-01], 141 86, Sweden

Location

Akademiska sjukhuset

Uppsala, Uppsala Län [se-03], 751 85, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

Location

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Université de Genève

Geneva, 1205, Switzerland

Location

China Medical University Hospital

Taichung, 404332, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan

Location

Local Institution - 0284

Stanbul, Istanbul, 34214, Turkey (Türkiye)

Location

Local Institution - 0283

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri

Ankara, 06230, Turkey (Türkiye)

Location

Local Institution - 0287

Ankara, 06560, Turkey (Türkiye)

Location

Local Institution - 0285

Istanbul, 34899, Turkey (Türkiye)

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Royal Free Hospital

London, England, NW32QG, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, London, City of, SE1 9RT, United Kingdom

Location

Sarah Cannon Research Institute UK

London, London, City of, w1g 6ad, United Kingdom

Location

Royal Marsden Hospital (Sutton)

London, Sutton, SM2 5PT, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 21, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): May 3, 2029
• Study Completion (Estimated): May 3, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

TU (5); KR (3); NL (4); ES (7); SL (4); CH (4); CN (28); HK (2); MY (3); ZA (4); SE (4); BE (7); BR (9); AU (3); DK (4); PL (5); SG (4); IE (1); CL (3); DE (10); FR (14); GR (7); IN (8); IT (9); CA (6); CO (4); GB (7); TW (4); US (48); RO (8); CZ (6); AR (6); IL (6); ME (8); JP (7)