AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaPhase 2/3NCT07076121

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)

A Phase 2/3 study testing Navlimetostat, Gemcitabine and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Bristol-Myers Squibb at 269 sites in 36 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Navlimetostat, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
470 participants
Where
269 sitesin 36 countries
Study dates
23 Oct 2025to 3 May 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

269 sites in 36 countries.

269 sites in 36 countries

United States48 sites

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Local Institution - 0371

    Baltimore, Maryland, 21201

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

  • St. Luke's Cancer Institute: Boise

    Boise, Idaho, 83712

  • Local Institution - 0120

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Local Institution - 0168

    Chicago, Illinois, 60637

  • Local Institution - 0376

    Columbus, Ohio, 43210

  • Texas Oncology - DFW

    Dallas, Texas, 75246

  • Brigitte Harris Cancer Pavilion

    Detroit, Michigan, 48202

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Uus Oncology

    Fort Worth, Texas, 76177

  • The Cancer & Hematology Centers

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Northwell Health/ RJ Zuckerberg Cancer Center

    Lake Success, New York, 11042

  • Local Institution - 0301

    Lancaster, Pennsylvania, 17601

  • Local Institution - 0370

    Louisville, Kentucky, 40202

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia, 30060

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    Mineola, New York, 11501

  • NYU Winthrop Hospital

    Mineola, New York, 11501

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Local Institution - 0279

    New York, New York, 10065

  • Local Institution - 0348

    Norfolk, Virginia, 23502

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68105

  • Thomas Jefferson University - Medical Oncology

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

  • Local Institution - 0368

    Pittsburgh, Pennsylvania, 15212

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

  • Local Institution - 0162

    Portland, Oregon, 97239

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

  • Wilmot Cancer Institute

    Rochester, New York, 14642

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Local Institution - 0157

    San Francisco, California, 94115

  • Local Institution - 0169

    Seattle, Washington, 98101

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Local Institution - 0170

    Temple, Texas, 76508

  • Local Institution - 0365

    Tucson, Arizona, 85724

  • Local Institution - 0125

    Westwood, Kansas, 66205

Other trials in United States

China28 sites

  • Local Institution - 0346

    Beijing, Beijing Municipality, 100021

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0293

    Changsha, Hunan, 421000

  • Local Institution - 0354

    Changzhou, Jiangsu, 213003

  • Sichuan Cancer hospital

    Chengdu, Sichuan, 610041

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610066

  • Local Institution - 0307

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0297

    Fuzhou, Fujian, 350014

  • Local Institution - 0352

    Guangzhou, Guangdong, 510080

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

    Guangzhou, Guangdong, 510120

  • Local Institution - 0356

    Hangzhou, Zhejiang, 310000

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Local Institution - 0302

    Harbin, Heilongjiang, 150081

  • Local Institution - 0312

    Hefei, Anhui, 230000

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230031

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Local Institution - 0334

    Jining, Shandong, 272029

  • Local Institution - 0295

    Luoyang, Henan, 471003

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

    Nanjing, Jiangsu, 210000

  • Local Institution - 0311

    Nanjing, Jiangsu, 210009

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0300

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0304

    Shenyang, Liaoning, 110042

  • Local Institution - 0351

    Taiyuan, Shanxi, 030000

  • Tianjin Tumor Hospital

    Tianjin, Tianjin Municipality, 300060

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Local Institution - 0353

    Zhengzhou, Henan, 450000

Other trials in China

France14 sites

  • Centre Hospitalier de la Côte Basque

    Bayonne, Pyrénées-Atlantiques, 64109

  • Chu Jean Minjoz

    Besançon, Doubs, 25000

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Auvergne, 63100

  • Centre Georges François Leclerc

    Dijon, Côte-d'Or, 21079

  • Local Institution - 0067

    Lyon, Auvergne-Rhône-Alpes, 69003

  • Institut Paoli-Calmettes

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

  • Local Institution - 0029

    Montpellier, Hérault, 34298

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021

  • Institut Curie - site Saint-Cloud

    Saint-Cloud, Hauts-de-Seine, 92210

  • CHU Rangueil

    Toulouse, Haute-Garonne, 31059

  • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

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

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94800

  • Hôpital Universitaire Paul Brousse

    Villejuif, 94800

Other trials in France

Germany10 sites

  • DRK Kliniken Berlin - Köpenick

    Berlin, 12559

  • St. Josef und St. Elisabeth Hospital gGmbH

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Chemnitz - Flemmingstraße

    Chemnitz, Saxony, 09116

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Technische Universitaet Dresden

    Dresden, Saxony, 01069

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, Hesse, 60488

  • Universitätsmedizin Göttingen - Georg-August-Universität

    Göttingen, Lower Saxony, 37075

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • TUM Klinikum

    München, Bavaria, 81675

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Brazil9 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784400

  • Hospital Mario Penna

    Belo Horizonte, Minas Gerais, 30380-472

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59062-000

  • Oncoclinicas Rio de Janeiro

    Rio de Janeiro, 22250-905

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

    Salvador, Estado de Bahia, 41253-190

  • Instituto de Oncologia Saint Gallen

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

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

  • Local Institution - 0332

    São Paulo, 01401-002

  • CEDOES

    Vitória, Espírito Santo, 29055450

Other trials in Brazil

Italy9 sites

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

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

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

    Rome, Lazio, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

    Verona, 37134

Other trials in Italy

India8 sites

  • Local Institution - 0179

    Bhubaneswar, Odisha, 751003

  • Local Institution - 0190

    Hyderabad, Telangana, 500032

  • Local Institution - 0147

    Hyderabad, Telangana, 500033

  • Local Institution - 0188

    Kochi, Kerala, 682041

  • Local Institution - 0153

    Kolkata, West Bengal, 700094

  • Local Institution - 0378

    Mumbai, Maharashtra, 400012

  • Local Institution - 0152

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0154

    Varanasi, Uttar Pradesh, 221005

Other trials in India

Mexico8 sites

  • Local Institution - 0261

    Cuauhtémoc, Ciudad de México, Mexico City, 06100

  • Local Institution - 0372

    Mérida, Yucatán, 97070

  • Local Institution - 0260

    Mexico City, Mexico City, 03100

  • Local Institution - 0264

    Monterrey, Nuevo León, 64460

  • Local Institution - 0265

    Oaxaca City, Oaxaca, 68020

  • Local Institution - 0262

    Puebla City, 72424

  • Local Institution - 0281

    Querétaro, 76000

  • Local Institution - 0364

    Zapopan, Jalisco, 45050

Other trials in Mexico

Romania8 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Spitalul Clinic Colțea

    Bucharest, 030171

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

    Cluj-Napoca, Cluj, 400162

  • Institutul Oncologic Cluj

    Cluj-Napoca, 400015

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

  • SC Radiotherapy Center Cluj SRL

    Florești, Cluj, 407280

  • Institutul Regional de Oncologie

    Iași, 700483

  • Spitalul Municipal Schuller Ploiești

    Ploieşti, 100337

Other trials in Romania

Australia7 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Local Institution - 0226

    Brisbane, Queensland, 4102

  • Cabrini Hospital - Malvern

    Malvern, Victoria, 3144

  • Northern Hospital

    Melbourne, Victoria, 3076

  • St. John of God Murdoch Hospital

    Murdoch, Western Australia, 6150

  • GenesisCare St Leonards

    St Leonards, New South Wales, 2065

  • Local Institution - 0229

    Woodville, South Australia, 5011

Other trials in Australia

Belgium7 sites

  • Institut Jules Bordet

    Anderlecht, Bruxelles-Capitale, Région de, 1070

  • Imelda General Hospital

    Bonheiden, Antwerpen, 2820

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région de, 1200

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

  • Local Institution - 0034

    Liège, 4000

Other trials in Belgium

Greece7 sites

  • Athens Medical Center - Psychikon branch

    Athens, Attikí (Region), 115 25

  • Aretaieio Hospital

    Athens, Attikí (Region), 115 28

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

  • University General Hospital of Heraklion

    Heraklion, Irakleío, 71500

  • University General Hospital of Larissa

    Larissa, Thessalía, 41110

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 540 07

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, Thessaloníki, 564 29

Other trials in Greece

Japan7 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto, Tokyo, 135-8550

  • Local Institution - 0222

    Nagoya, Aichi-ken, 464-8681

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Local Institution - 0219

    Sapporo, Hokkaido, 060-8543

  • Kanagawa cancer center

    Yokohama, Kanagawa, 2418515

Other trials in Japan

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United Kingdom7 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England, B15 2TH

  • Royal Free Hospital

    London, England, NW32QG

  • Guy's & St Thomas' NHS Foundation Trust

    London, London, City of, SE1 9RT

  • Sarah Cannon Research Institute UK

    London, London, City of, w1g 6ad

  • Royal Marsden Hospital (Sutton)

    London, Sutton, SM2 5PT

  • The Royal Marsden Hospital

    London, SW3 6JJ

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

Other trials in United Kingdom

Argentina6 sites

  • Hospital Italiano de Buenos Aires

    ABB, Buenos Aires F.D., C1199ABB

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

    Buenos Aires, 1431

  • Hospital Británico de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

  • Instituto Alexander Fleming

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Sanatorio Allende - Nueva Córdoba

    Córdoba, 5000

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

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Canada6 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Local Institution - 0202

    Halifax, Nova Scotia, B3H 2Y9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0200

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia6 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

  • Fakultni nemocnice Motol a Homolka

    Prague, Praha 5, 150 06

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Israel6 sites

  • Local Institution - 0077

    Afula, Northern District, 1834111

  • Local Institution - 0097

    Jerusalem, Jerusalem, 9112001

  • Local Institution - 0081

    Petah Tikva, 4941492

  • Local Institution - 0078

    Ramat Gan, Central District, 5265601

  • Local Institution - 0076

    Tel Aviv, Tell Abīb, 6423906

  • Local Institution - 0080

    Ẕerifin, Central District, 70300

Other trials in Israel

Poland5 sites

  • COPERNICUS PL, Wojewodzkie Centrum Onkologii

    Gdansk, Pomeranian Voivodeship, 80-219

  • Local Institution - 0251

    Gdask, Pomeranian Voivodeship, 80-952

  • Centrum Medyczne Pratia Poznań

    Poznan, Greater Poland Voivodeship, 60-192

  • Centrum Medyczne Pratia Warszawa

    Warsaw, Masovian Voivodeship, 02-172

  • Local Institution - 0379

    Warsaw, 02-781

Other trials in Poland

Turkey (Türkiye)5 sites

  • Local Institution - 0283

    Adana, 01250

  • Hacettepe Universite Hastaneleri

    Ankara, 06230

  • Local Institution - 0287

    Ankara, 06560

  • Local Institution - 0285

    Istanbul, 34899

  • Local Institution - 0284

    Stanbul, Istanbul, 34214

Other trials in Turkey (Türkiye)

Colombia4 sites

  • Local Institution - 0266

    Bogotá, 110411

  • Local Institution - 0267

    Medellín, Antioquia, 050030

  • Local Institution - 0269

    Montería, Departamento de Córdoba, 230002

  • Local Institution - 0338

    Rionegro, Antioquia, 054047

Other trials in Colombia

Denmark4 sites

  • Local Institution - 0021

    Aalborg, North Denmark, 9000

  • Herlev and Gentofte Hospital

    Copenhagen, Capital Region, 2730

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Netherlands4 sites

  • Local Institution - 0039

    Breda, North Brabant, 4818 CK

  • Local Institution - 0277

    Leiden, South Holland, 2333 ZA

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Singapore4 sites

  • National Cancer Centre Singapore

    Singapore, Central Singapore, 168583

  • National University Hospital

    Singapore, 119074

  • Local Institution - 0252

    Singapore, 308433

  • Local Institution - 0253

    Singapore, 329563

Other trials in Singapore

Slovakia4 sites

  • Local Institution - 0272

    Banská Bystrica, 97517

  • Local Institution - 0275

    Bratislava, 83101

  • Local Institution - 0273

    Košice, Košice Region, 041 91

  • Local Institution - 0274

    Trenčín, Trenčín Region, 911 01

Other trials in Slovakia

South Africa4 sites

  • Local Institution - 0335

    Cape Town, Western Cape, 7937

  • Local Institution - 0246

    Johannesburg, 2193

  • Local Institution - 0241

    Pretoria, 0001

  • Local Institution - 0240

    Soweto, Gauteng, 2013

Other trials in South Africa

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset

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

  • Skånes Universitetssjukhus Lund

    Lund, Skåne Län [se-12], 22185

  • Karolinska Universitetssjukhuset Huddinge

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

  • Akademiska sjukhuset

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

Other trials in Sweden

Switzerland4 sites

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, Canton Ticino, 6500

  • Inselspital Bern

    Bern, Canton of Bern, 3010

  • Université de Genève

    Geneva, 1205

  • Cantonal Hospital St.Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 404332

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Austria3 sites

  • Ordensklinikum Linz

    Linz, Upper Austria, 4010

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Chile3 sites

  • FALP

    Santiago, Santiago Metropolitan, 7500921

  • Clínica UC San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7620002

  • Bradfordhill

    Santiago, Santiago Metropolitan, 8420383

Other trials in Chile

Malaysia3 sites

  • Local Institution - 0258

    Kuala Lumpur, Kuala Lumpur, 50586

  • Local Institution - 0257

    Kuching, Sarawak, 93586

  • Local Institution - 0256

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Local Institution - 0270

    Shatin, NT

Other trials in Hong Kong

Ireland1 site

  • St. Vincent's University Hospital

    Dublin, D04 T6F4

Other trials in Ireland

About this study

Official title: 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.

Being tested
Navlimetostat, Gemcitabine, Nab-paclitaxel, Placebo
Keywords
PRMT5, MTAP, MRTX1719, MountainTAP, Pancreatic cancer, PDAC
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavlimetostatDrug

    Also called BMS-986504, MRTX1719

    Specified dose on specified days

  • GemcitabineDrug

    Specified dose on specified days

  • Nab-paclitaxelDrug

    Also called Abraxane

    Specified dose on specified days

  • PlaceboDrug

    Specified dose on specified days

Study groups in NCT07076121
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel
Arm BExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel
Arm CPlacebo comparatorNot described
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo
Arm DPlacebo comparatorNot described
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo
Arm EExperimentalNot described
Receives: Drug: Navlimetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel
Arm FPlacebo comparatorNot described
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 3 years after last participant is randomized

  2. Overall Survival (OS)

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

    Measured: Up to 3 years after last participant is randomized

Secondary outcomes (10)

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

    Measured: Up to 3 years after last participant is randomized

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

    Defined as the time between the date of the first documentation of objective tumor response (complete response (CR) or partial response (PR)) and the date of disease progression or to death from any cause (whichever occurs first)

    Measured: Up to 3 years after last participant is randomized

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

    Defined as the time between randomization to the date of the first documentation of objective tumor response

    Measured: Up to 3 years after last participant is randomized

  4. Disease control as assessed by RECIST v1.1

    Defined as the best overall response (BOR) of confirmed CR, PR, or stable disease (SD)

    Measured: Up to 3 years after last participant is randomized

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

    Measured: Up to 28 days after the last drug administration

  6. Number of participants with all-cause treatment-emergent adverse events (TEAEs)

    Measured: Up to 28 days after the last drug administration

  7. Number of participants with treatment-emergent serious adverse events (TESAEs)

    Measured: Up to 28 days after the last drug administration

  8. Number of participants with TEAEs leading to dose interruption, reduction, or discontinuation

    Measured: Up to 28 days after the last drug administration

  9. Number of participants with laboratory abnormalities

    Measured: Up to 28 days after the last drug administration

  10. PFS as assessed by RECIST v1.1

    Measured: Up to 3 years after last participant is randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2025
  2. Study start23 Oct 2025
  3. Primary completion3 May 2029 (estimated)
  4. Study completion3 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
470 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07076121
Sponsor's protocol ID
CA240-0030
Other IDs
2025-522598-12, U1111-1320-4708, CA2400030, 2025
Status last verified
Jun 2026
First submitted
14 Jul 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Navlimetostat, Gemcitabine and Nab-paclitaxel in people with Pancreatic Ductal Adenocarcinoma, run by Bristol-Myers Squibb at 269 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in United States, China, France, Germany, Brazil and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1) (time frame: Up to 3 years after last participant is randomized). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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