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)
Launched by BRISTOL-MYERS SQUIBB · Jul 14, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment option for people with a type of advanced pancreatic cancer called metastatic pancreatic ductal adenocarcinoma (PDAC). Specifically, it’s looking at whether adding a medicine called BMS-986504 to a standard chemotherapy treatment (nab-paclitaxel and gemcitabine) is safe and helps control the cancer better than chemotherapy alone. This study focuses on patients whose tumors have a specific genetic change known as homozygous MTAP deletion, which may make them respond differently to this new treatment.
To join this study, participants need to have confirmed metastatic pancreatic cancer that has not been treated with systemic therapy before, and their tumor must show the MTAP deletion. Patients should have at least one measurable tumor and must be adults between 65 and 74 years old. Participants may have received one initial cycle of the standard chemotherapy but no more before starting the study. During the trial, patients will receive either the new medication plus chemotherapy or a placebo (a treatment with no active medicine) plus chemotherapy. The goal is to see how well the new medicine works and how safe it is. It’s important to know that this trial is not yet open for enrollment, and certain other health conditions or recent cancers may prevent someone from joining.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Taipei, , Taiwan
Hradec Kralove, , Czechia
Madrid, , Spain
Sevilla, , Spain
Milwaukee, Wisconsin, United States
New York, New York, United States
Santiago, , Chile
Santiago, , Chile
Solna, , Sweden
Phoenix, Arizona, United States
Springdale, Arkansas, United States
San Francisco, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Westwood, Kansas, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Abb, , Argentina
San Miguel De Tucuman, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
St Leonards, New South Wales, Australia
Brisbane, Queensland, Australia
Brisbane, Queensland, Australia
Woodville, South Australia, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Murdoch, Western Australia, Australia
Linz, , Austria
Salzburg, , Austria
Wien, , Austria
Bonheiden, Antwerpen, Belgium
Edegem, Antwerpen, Belgium
Brussels, , Belgium
Brussels, , Belgium
Gent, Oost Vlaanderen, Belgium
Leuven, Vlaams Brabant, Belgium
Liège, , Belgium
Salvador, Bahia, Brazil
Vitória, , Brazil
Belo Horizonte, Minas Gerais, Brazil
Natal, Rio Grande Do Norte, Brazil
Santa Cruz Do Sul, Rio Grande Do Sul, Brazil
Barretos, , Brazil
Rio De Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Viña Del Mar, , Chile
Hefei, Anhui, China
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Luoyang, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Shenyang, Liaoning, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
Jining, Shandong, China
Shanghai Shi, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Cheng Du, Sichuan, China
Chengdu, Sichuan, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Medellín, Antioquia, Colombia
Montería, , Colombia
Pereira, Risaralda, Colombia
Bogotá, , Colombia
Brno, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Praha, , Czechia
Praha 2, , Czechia
Copenhagen, Hovedstaden, Denmark
Aarhus, Midtjylland, Denmark
Aalborg, Nordjylland, Denmark
Odense, Syddanmark, Denmark
Vejle, Syddanmark, Denmark
Clermont Ferrand, Auvergne, France
Dijon, , France
Besançon, Doubs, France
Toulouse, Haute Garonne, France
Saint Cloud, Hauts De Seine, France
Montpellier, , France
Vandoeuvre Lès Nancy, Meurthe Et Moselle, France
Marseille, , France
Bayonne, , France
Lyon, , France
Villejuif, Val De Marne, France
Poitiers, Vienne, France
Paris, , France
Villejuif, , France
München, Bayern, Germany
Frankfurt, Hessen, Germany
Göttingen, Niedersachsen, Germany
Bochum, Nordrhein Westfalen, Germany
Chemnitz, Sachsen, Germany
Dresden, Sachsen, Germany
Berlin, , Germany
Hamburg, , Germany
Köln, , Germany
Ulm, , Germany
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Larissa, , Greece
Athens, , Greece
Hong Kong, , Hong Kong
Shatin, , Hong Kong
New Delhi, Delhi, India
Kochi, Kerala, India
Bhubaneswar, Odisha, India
Hyderabad, Telangana, India
Hyderabad, Telangana, India
Varanasi, Uttar Pradesh, India
Kolkata, West Bengal, India
Dublin, , Ireland
Ramat Gan, Hamerkaz, Israel
Zerifin, Hamerkaz, Israel
Afula, Hatsafon, Israel
Tel Aviv, , Israel
Jerusalem, Yerushalayim, Israel
Petah Tikva, , Israel
Naples, Campania, Italy
Meldola, Emilia Romagna, Italy
Roma, Lazio, Italy
Milan, Lombardia, Italy
Rozzano, Milano, Italy
Pisa, Toscana, Italy
Padova, Veneto, Italy
Milano, , Italy
Verona, , Italy
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Chuo Ku, Tokyo, Japan
Koto, Tokyo, Japan
Osaka, , Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kuching, Sarawak, Malaysia
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Lembah Pantai, Wilayah Persekutuan Kuala Lumpur, Malaysia
Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Monterrey, , Mexico
Oaxaca De Juarez, Oaxaca, Mexico
Mexico City, , Mexico
Puebla, , Mexico
Maastricht, Limburg, Netherlands
Breda, Noord Brabant, Netherlands
Leiden, Zuid Holland, Netherlands
Rotterdam, Zuid Holland, Netherlands
Warszawa, Mazowieckie, Poland
Gdask, Pomorskie, Poland
Poznań, Wielkopolskie, Poland
Cluj Napoca, Cluj, Romania
Florești, Cluj, Romania
Craiova, Dolj, Romania
Ploiești, Prahova, Romania
București, , Romania
București, , Romania
Cluj, , Romania
Cluj, , Romania
Iași, , Romania
Singapore, Central Singapore, Singapore
Singapore, , Singapore
Singapore, , Singapore
Singapore, , Singapore
Banska Bystrica, , Slovakia
Kosice, , Slovakia
Trencin, , Slovakia
Bratislava, , Slovakia
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Soweto, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Zaragoza, , Spain
Lund, , Sweden
Uppsala, , Sweden
Gothenburg, , Sweden
Bern, Berne, Switzerland
St.Gallen, Sankt Gallen, Switzerland
Bellinzona, Ticino, Switzerland
Geneva, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
Stanbul, , Turkey
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Birmingham, England, United Kingdom
London, England, United Kingdom
London, Kensington And Chelsea, United Kingdom
London, , United Kingdom
London, , United Kingdom
Wirral, , United Kingdom
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changzhou, Jiangsu, China
Shanghai, Shanghai, China
Taiyuan, Shanxi, China
Hangzhou, Zhejiang, China
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported