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
Status: Recruiting
Location: See all (269) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Local Institution - 0142
NOT_YET_RECRUITING
Phoenix
Local Institution - 0365
NOT_YET_RECRUITING
Tucson
California
Local Institution - 0373
NOT_YET_RECRUITING
La Jolla
Local Institution - 0157
NOT_YET_RECRUITING
San Francisco
Florida
Local Institution - 0139
NOT_YET_RECRUITING
Jacksonville
Local Institution - 0132
WITHDRAWN
Tampa
Georgia
Local Institution - 0367
NOT_YET_RECRUITING
Atlanta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING
Marietta
Idaho
Local Institution - 0126
NOT_YET_RECRUITING
Boise
Illinois
Local Institution - 0168
NOT_YET_RECRUITING
Chicago
Kansas
Local Institution - 0125
NOT_YET_RECRUITING
Westwood
Kentucky
Local Institution - 0370
NOT_YET_RECRUITING
Louisville
Massachusetts
Local Institution - 0120
NOT_YET_RECRUITING
Boston
Local Institution - 0245
NOT_YET_RECRUITING
Boston
Maryland
Local Institution - 0145
NOT_YET_RECRUITING
Baltimore
Local Institution - 0371
NOT_YET_RECRUITING
Baltimore
Michigan
Local Institution - 0191
NOT_YET_RECRUITING
Detroit
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
Minnesota
Local Institution - 0182
NOT_YET_RECRUITING
Rochester
North Carolina
Local Institution - 0129
NOT_YET_RECRUITING
Chapel Hill
Nebraska
Local Institution - 0290
NOT_YET_RECRUITING
Omaha
New York
Local Institution - 0144
NOT_YET_RECRUITING
Buffalo
Local Institution - 0377
NOT_YET_RECRUITING
Mineola
Local Institution - 0146
NOT_YET_RECRUITING
New Hyde Park
Local Institution - 0140
NOT_YET_RECRUITING
New York
Local Institution - 0143
NOT_YET_RECRUITING
New York
Local Institution - 0279
NOT_YET_RECRUITING
New York
Local Institution - 0161
NOT_YET_RECRUITING
Rochester
Oregon
Kaiser Permanente Center for Health Research
RECRUITING
Portland
Local Institution - 0162
NOT_YET_RECRUITING
Portland
Pennsylvania
St. Luke's University Health Network
RECRUITING
Bethlehem
Local Institution - 0301
NOT_YET_RECRUITING
Lancaster
Local Institution - 0158
NOT_YET_RECRUITING
Philadelphia
Local Institution - 0289
NOT_YET_RECRUITING
Pittsburgh
Local Institution - 0368
NOT_YET_RECRUITING
Pittsburgh
Tennessee
Local Institution - 0167
NOT_YET_RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Local Institution - 0196
NOT_YET_RECRUITING
Dallas
Local Institution - 0164
NOT_YET_RECRUITING
Houston
Local Institution - 0170
NOT_YET_RECRUITING
Temple
Utah
Local Institution - 0344
NOT_YET_RECRUITING
Salt Lake City
Virginia
Local Institution - 0159
NOT_YET_RECRUITING
Fairfax
Local Institution - 0348
NOT_YET_RECRUITING
Norfolk
Washington
Local Institution - 0169
NOT_YET_RECRUITING
Seattle
Local Institution - 0337
NOT_YET_RECRUITING
Seattle
Wisconsin
Local Institution - 0195
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
Local Institution - 0044
NOT_YET_RECRUITING
Abb
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC)
RECRUITING
Buenos Aires
Local Institution - 0041
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0042
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0045
NOT_YET_RECRUITING
Córdoba
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Australia
Local Institution - 0226
NOT_YET_RECRUITING
Brisbane
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Local Institution - 0232
NOT_YET_RECRUITING
Malvern
Local Institution - 0231
NOT_YET_RECRUITING
Melbourne
St. John of God Murdoch Hospital
RECRUITING
Murdoch
GenesisCare North Shore
RECRUITING
St Leonards
Local Institution - 0229
NOT_YET_RECRUITING
Woodville
Austria
Local Institution - 0213
NOT_YET_RECRUITING
Linz
Local Institution - 0223
NOT_YET_RECRUITING
Salzburg
Local Institution - 0211
NOT_YET_RECRUITING
Vienna
Belgium
Local Institution - 0031
NOT_YET_RECRUITING
Bonheiden
Local Institution - 0063
NOT_YET_RECRUITING
Brussels
Local Institution - 0065
NOT_YET_RECRUITING
Brussels
Local Institution - 0035
NOT_YET_RECRUITING
Edegem
Local Institution - 0033
NOT_YET_RECRUITING
Ghent
Local Institution - 0032
NOT_YET_RECRUITING
Leuven
Local Institution - 0034
NOT_YET_RECRUITING
Liège
Brazil
Local Institution - 0071
NOT_YET_RECRUITING
Barretos
Local Institution - 0101
NOT_YET_RECRUITING
Belo Horizonte
Local Institution - 0074
NOT_YET_RECRUITING
Natal
Local Institution - 0100
NOT_YET_RECRUITING
Rio De Janeiro
Local Institution - 0291
NOT_YET_RECRUITING
Salvador
Local Institution - 0104
NOT_YET_RECRUITING
Santa Cruz Do Sul
Local Institution - 0075
NOT_YET_RECRUITING
São Paulo
Local Institution - 0332
NOT_YET_RECRUITING
São Paulo
Local Institution - 0102
NOT_YET_RECRUITING
Vitória
Canada
Local Institution - 0199
NOT_YET_RECRUITING
Calgary
Local Institution - 0202
NOT_YET_RECRUITING
Halifax
Local Institution - 0215
NOT_YET_RECRUITING
Montreal
Local Institution - 0201
NOT_YET_RECRUITING
Toronto
Local Institution - 0203
NOT_YET_RECRUITING
Toronto
Local Institution - 0200
NOT_YET_RECRUITING
Vancouver
Chile
Local Institution - 0046
NOT_YET_RECRUITING
Santiago
Local Institution - 0047
NOT_YET_RECRUITING
Santiago
Local Institution - 0048
NOT_YET_RECRUITING
Santiago
Local Institution - 0156
WITHDRAWN
Viña Del Mar
China
Local Institution - 0310
NOT_YET_RECRUITING
Beijing
Local Institution - 0346
NOT_YET_RECRUITING
Beijing
Local Institution - 0293
NOT_YET_RECRUITING
Changsha
Local Institution - 0354
NOT_YET_RECRUITING
Changzhou
Local Institution - 0305
NOT_YET_RECRUITING
Chengdu
Local Institution - 0308
NOT_YET_RECRUITING
Chengdu
Local Institution - 0307
NOT_YET_RECRUITING
Chongqing
Local Institution - 0296
WITHDRAWN
Fuzhou
Local Institution - 0297
NOT_YET_RECRUITING
Fuzhou
Local Institution - 0313
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0352
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0294
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0356
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0302
NOT_YET_RECRUITING
Harbin
Local Institution - 0312
NOT_YET_RECRUITING
Hefei
Local Institution - 0331
NOT_YET_RECRUITING
Hefei
Local Institution - 0299
NOT_YET_RECRUITING
Jinan
Local Institution - 0334
NOT_YET_RECRUITING
Jining
Local Institution - 0295
NOT_YET_RECRUITING
Luoyang
Local Institution - 0303
NOT_YET_RECRUITING
Nanjing
Local Institution - 0311
NOT_YET_RECRUITING
Nanjing
Local Institution - 0292
NOT_YET_RECRUITING
Shanghai
Local Institution - 0300
NOT_YET_RECRUITING
Shanghai
Local Institution - 0355
WITHDRAWN
Shanghai
Local Institution - 0239
WITHDRAWN
Shanghai Shi
Local Institution - 0304
NOT_YET_RECRUITING
Shenyang
Local Institution - 0351
NOT_YET_RECRUITING
Taiyuan
Local Institution - 0314
NOT_YET_RECRUITING
Tianjin
Local Institution - 0298
WITHDRAWN
Wuhan
Local Institution - 0357
NOT_YET_RECRUITING
Wuhan
Local Institution - 0345
NOT_YET_RECRUITING
Xi'an
Local Institution - 0353
NOT_YET_RECRUITING
Zhengzhou
Colombia
Local Institution - 0266
NOT_YET_RECRUITING
Bogotá
Local Institution - 0267
NOT_YET_RECRUITING
Medellín
Local Institution - 0269
NOT_YET_RECRUITING
Montería
Local Institution - 0268
WITHDRAWN
Pereira
Local Institution - 0338
NOT_YET_RECRUITING
Rionegro
Local Institution - 0362
WITHDRAWN
Rionegro
Denmark
Local Institution - 0021
NOT_YET_RECRUITING
Aalborg
Local Institution - 0116
WITHDRAWN
Aarhus
Local Institution - 0019
NOT_YET_RECRUITING
Copenhagen
Local Institution - 0020
NOT_YET_RECRUITING
Odense
Local Institution - 0018
NOT_YET_RECRUITING
Vejle
France
Local Institution - 0276
NOT_YET_RECRUITING
Bayonne
Local Institution - 0062
NOT_YET_RECRUITING
Besançon
Local Institution - 0180
NOT_YET_RECRUITING
Clermont-ferrand
Local Institution - 0064
NOT_YET_RECRUITING
Dijon
Local Institution - 0067
NOT_YET_RECRUITING
Lyon
Local Institution - 0238
NOT_YET_RECRUITING
Marseille
Local Institution - 0029
NOT_YET_RECRUITING
Montpellier
Local Institution - 0028
NOT_YET_RECRUITING
Paris
Local Institution - 0066
NOT_YET_RECRUITING
Poitiers
Local Institution - 0068
NOT_YET_RECRUITING
Saint-cloud
Local Institution - 0026
NOT_YET_RECRUITING
Toulouse
Local Institution - 0025
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Local Institution - 0030
NOT_YET_RECRUITING
Villejuif
Local Institution - 0309
NOT_YET_RECRUITING
Villejuif
Germany
Local Institution - 0236
NOT_YET_RECRUITING
Berlin
Local Institution - 0205
NOT_YET_RECRUITING
Bochum
Local Institution - 0243
NOT_YET_RECRUITING
Chemnitz
Local Institution - 0206
NOT_YET_RECRUITING
Cologne
Local Institution - 0224
NOT_YET_RECRUITING
Dresden
Local Institution - 0209
NOT_YET_RECRUITING
Frankfurt Am Main
Local Institution - 0204
NOT_YET_RECRUITING
Göttingen
Local Institution - 0207
NOT_YET_RECRUITING
Hamburg
Local Institution - 0242
NOT_YET_RECRUITING
München
Local Institution - 0208
NOT_YET_RECRUITING
Ulm
Greece
Local Institution - 0084
NOT_YET_RECRUITING
Athens
Local Institution - 0085
NOT_YET_RECRUITING
Athens
Local Institution - 0086
NOT_YET_RECRUITING
Athens
Local Institution - 0259
NOT_YET_RECRUITING
Heraklion
Local Institution - 0083
NOT_YET_RECRUITING
Larissa
Local Institution - 0082
NOT_YET_RECRUITING
Thessaloniki
Local Institution - 0091
NOT_YET_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Local Institution - 0271
NOT_YET_RECRUITING
Hong Kong
Local Institution - 0270
NOT_YET_RECRUITING
Shatin
India
Local Institution - 0179
NOT_YET_RECRUITING
Bhubaneswar
Local Institution - 0147
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0190
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0188
NOT_YET_RECRUITING
Kochi
Local Institution - 0153
NOT_YET_RECRUITING
Kolkata
Local Institution - 0152
NOT_YET_RECRUITING
New Delhi
Local Institution - 0154
NOT_YET_RECRUITING
Varanasi
Ireland
Local Institution - 0225
NOT_YET_RECRUITING
Dublin
Israel
Local Institution - 0077
NOT_YET_RECRUITING
Afula
Local Institution - 0097
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0081
NOT_YET_RECRUITING
Petah Tikva
Local Institution - 0078
NOT_YET_RECRUITING
Ramat Gan
Local Institution - 0076
NOT_YET_RECRUITING
Tel Aviv
Local Institution - 0080
NOT_YET_RECRUITING
Ẕerifin
Italy
Local Institution - 0095
NOT_YET_RECRUITING
Meldola
Local Institution - 0089
NOT_YET_RECRUITING
Milan
Local Institution - 0247
NOT_YET_RECRUITING
Milan
Local Institution - 0094
NOT_YET_RECRUITING
Naples
Local Institution - 0093
NOT_YET_RECRUITING
Padua
Local Institution - 0096
NOT_YET_RECRUITING
Pisa
Local Institution - 0092
NOT_YET_RECRUITING
Rome
Local Institution - 0088
NOT_YET_RECRUITING
Rozzano
Local Institution - 0090
NOT_YET_RECRUITING
Verona
Japan
Local Institution - 0216
NOT_YET_RECRUITING
Chuo-ku
Local Institution - 0217
NOT_YET_RECRUITING
Kashiwa
Local Institution - 0220
NOT_YET_RECRUITING
Koto
Local Institution - 0222
NOT_YET_RECRUITING
Nagoya
Local Institution - 0221
NOT_YET_RECRUITING
Osaka
Local Institution - 0219
NOT_YET_RECRUITING
Sapporo
Local Institution - 0218
NOT_YET_RECRUITING
Yokohama
Malaysia
Local Institution - 0258
NOT_YET_RECRUITING
Kuala Lumpur
Local Institution - 0257
NOT_YET_RECRUITING
Kuching
Local Institution - 0256
NOT_YET_RECRUITING
Lembah Pantai
Mexico
Local Institution - 0261
NOT_YET_RECRUITING
Cuauhtémoc, Ciudad De México
Local Institution - 0372
NOT_YET_RECRUITING
Mérida
Local Institution - 0260
NOT_YET_RECRUITING
Mexico City
Local Institution - 0263
WITHDRAWN
Mexico City
Local Institution - 0264
NOT_YET_RECRUITING
Monterrey
Local Institution - 0265
NOT_YET_RECRUITING
Oaxaca City
Local Institution - 0262
NOT_YET_RECRUITING
Puebla City
Local Institution - 0281
NOT_YET_RECRUITING
Querétaro City
Local Institution - 0364
NOT_YET_RECRUITING
Zapopan
Netherlands
Local Institution - 0039
NOT_YET_RECRUITING
Breda
Local Institution - 0277
NOT_YET_RECRUITING
Leiden
Local Institution - 0038
NOT_YET_RECRUITING
Maastricht
Local Institution - 0037
NOT_YET_RECRUITING
Rotterdam
Poland
Local Institution - 0363
NOT_YET_RECRUITING
Gdansk
Local Institution - 0251
NOT_YET_RECRUITING
Gdask
Local Institution - 0278
NOT_YET_RECRUITING
Poznan
Local Institution - 0280
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Local Institution - 0050
NOT_YET_RECRUITING
Seoul
Local Institution - 0051
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Romania
Local Institution - 0109
NOT_YET_RECRUITING
Bucharest
Local Institution - 0114
NOT_YET_RECRUITING
Bucharest
Local Institution - 0112
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0113
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0115
NOT_YET_RECRUITING
Cluj-napoca
Local Institution - 0110
NOT_YET_RECRUITING
Craiova
Local Institution - 0111
NOT_YET_RECRUITING
Florești
Local Institution - 0107
NOT_YET_RECRUITING
Iași
Local Institution - 0108
NOT_YET_RECRUITING
Ploieşti
Singapore
Local Institution - 0252
NOT_YET_RECRUITING
Singapore
Local Institution - 0253
NOT_YET_RECRUITING
Singapore
Local Institution - 0254
NOT_YET_RECRUITING
Singapore
Local Institution - 0255
NOT_YET_RECRUITING
Singapore
Slovakia
Local Institution - 0272
NOT_YET_RECRUITING
Banská Bystrica
Local Institution - 0275
NOT_YET_RECRUITING
Bratislava
Local Institution - 0273
NOT_YET_RECRUITING
Košice
Local Institution - 0274
NOT_YET_RECRUITING
Trenčín
South Africa
Local Institution - 0335
NOT_YET_RECRUITING
Cape Town
Local Institution - 0246
NOT_YET_RECRUITING
Johannesburg
Local Institution - 0241
NOT_YET_RECRUITING
Pretoria
Local Institution - 0240
NOT_YET_RECRUITING
Soweto
Spain
Local Institution - 0003
NOT_YET_RECRUITING
Barcelona
Local Institution - 0005
NOT_YET_RECRUITING
Barcelona
Local Institution - 0002
NOT_YET_RECRUITING
Madrid
Local Institution - 0004
NOT_YET_RECRUITING
Madrid
Local Institution - 0007
NOT_YET_RECRUITING
Madrid
Local Institution - 0006
NOT_YET_RECRUITING
Seville
Local Institution - 0001
NOT_YET_RECRUITING
Zaragoza
Sweden
Local Institution - 0118
NOT_YET_RECRUITING
Gothenburg
Local Institution - 0249
NOT_YET_RECRUITING
Lund
Local Institution - 0023
NOT_YET_RECRUITING
Stockholm
Local Institution - 0022
NOT_YET_RECRUITING
Uppsala
Switzerland
Ospedale Regionale Bellinzona e Valli
RECRUITING
Bellinzona
Inselspital Bern
RECRUITING
Bern
Local Institution - 0234
NOT_YET_RECRUITING
Geneva
Cantonal Hospital St.Gallen
RECRUITING
Sankt Gallen
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Local Institution - 0283
NOT_YET_RECRUITING
Adana
Local Institution - 0286
NOT_YET_RECRUITING
Ankara
Local Institution - 0287
NOT_YET_RECRUITING
Ankara
Local Institution - 0285
NOT_YET_RECRUITING
Istanbul
Local Institution - 0284
NOT_YET_RECRUITING
Stanbul
United Kingdom
Local Institution - 0098
NOT_YET_RECRUITING
Birmingham
Local Institution - 0013
NOT_YET_RECRUITING
London
Local Institution - 0014
NOT_YET_RECRUITING
London
Local Institution - 0017
NOT_YET_RECRUITING
London
Local Institution - 0248
NOT_YET_RECRUITING
London
Local Institution - 0235
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2029-05-03
Participants
Target number of participants: 470
Treatments
Experimental: Arm A
Experimental: Arm B
Placebo_comparator: Arm C
Placebo_comparator: Arm D
Experimental: Arm E
Placebo_comparator: Arm F
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb