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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)
Sponsor: Bristol-Myers Squibb
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.
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
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
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Navlimetostat
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 (269)
Mayo Clinic in Arizona - Phoenix
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
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
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
Johns Hopkins Hospital
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
Mayo Clinic in Rochester, Minnesota
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
Icahn School of Medicine at Mount Sinai
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
Thomas Jefferson University - Medical Oncology
Philadelphia, Pennsylvania, United States
Local Institution - 0368
Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center
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
Uus Oncology
Fort Worth, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Local Institution - 0170
Temple, Texas, United States
LDS Hospital
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
Medical College of Wisconsin
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
Hospital Italiano de Buenos Aires
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
Medizinische Universität Wien
Vienna, Austria
Imelda General Hospital
Bonheiden, Antwerpen, Belgium
Antwerp University Hospital
Edegem, Antwerpen, Belgium
Institut Jules Bordet
Anderlecht, Bruxelles-Capitale, Région de, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Local Institution - 0034
Liège, Belgium
CEDOES
Vitória, Espírito Santo, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, Brazil
Hospital Mario Penna
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Câncer
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
Oncoclinicas Rio de Janeiro
Rio de Janeiro, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
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
FALP
Santiago, Santiago Metropolitan, Chile
Clínica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, Chile
Bradfordhill
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 - 0297
Fuzhou, Fujian, China
Local Institution - 0352
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Local Institution - 0302
Harbin, Heilongjiang, China
Local Institution - 0295
Luoyang, Henan, China
Local Institution - 0353
Zhengzhou, Henan, China