A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
MountainTAP-29
A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
4 other identifiers
interventional
590
33 countries
303
Brief Summary
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2026
Longer than P75 for phase_2
303 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 14, 2025
CompletedStudy Start
First participant enrolled
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2031
June 5, 2026
June 1, 2026
5.6 years
July 3, 2025
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Progression-free survival (PFS) by RECIST v1.1
Phase 2
Up to 2 years
PFS by RECIST v1.1 per BICR
Phase 3
Up to 5 years
Overall Survival (OS)
Phase 3
Up to 5 years
Secondary Outcomes (12)
Objective response (OR) (confirmed complete response (CR) or partial response (PR))
Up to 2 years
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
Up to 2 years
Duration of response (DOR) (CR or PR)
Up to 2 years
Time to objective response (TTOR) (CR or PR)
Up to 2 years
Number of participants with treatment-related and all-cause adverse events (AEs)
Up to 90 days from the last dose
- +7 more secondary outcomes
Study Arms (6)
Arm A: BMS-986504 + Pembrolizumab + Chemotherapy
ACTIVE COMPARATORArm B: BMS-986504 + Pembrolizumab + Chemotherapy
ACTIVE COMPARATORArm C: Placebo + Pembrolizumab + Chemotherapy
PLACEBO COMPARATORArm D: Placebo + Pembrolizumab + Chemotherapy
PLACEBO COMPARATORArm E: BMS-986504 + Pembrolizumab + Chemotherapy
ACTIVE COMPARATORArm F: Placebo + Pembrolizumab + Chemotherapy
PLACEBO COMPARATORInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
- Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Participants must have at least 1 measurable lesion as per RECIST v1.1.
You may not qualify if:
- Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
- Participants must not have symptomatic brain metastases or spinal cord compression.
- Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).
- Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
- Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (311)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Local Institution - 0497
Los Alamitos, California, 90720, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Local Institution - 0444
Los Angeles, California, 90067, United States
Local Institution - 0606
Newark, Delaware, 19713, United States
Helios Clinical Research - Fort Lauderdale
Fort Lauderdale, Florida, 33316, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Local Institution - 0430
St. Petersburg, Florida, 33709, United States
St. Luke's Cancer Institute: Boise
Boise, Idaho, 83712, United States
Local Institution - 0605
Decatur, Illinois, 62526, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Local Institution - 0127
Scarborough, Maine, 04074, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Local Institution - 0418
Ann Arbor, Michigan, 48109, United States
Local Institution - 0405
Detroit, Michigan, 48201, United States
Local Institution - 0420
Traverse City, Michigan, 49684, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
Local Institution - 0467
Lebanon, New Hampshire, 03756, United States
Local Institution - 0600
Manchester, New Hampshire, 03103, United States
WMCHealth Advanced Physician Services
Hawthorne, New York, 10532, United States
Local Institution - 0128
Rochester, New York, 14642, United States
Local Institution - 0518
Schenectady, New York, 12308, United States
Local Institution - 0514
Winston-Salem, North Carolina, 27157, United States
Local Institution - 0163
Cleveland, Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227, United States
Local Institution - 0608
Greenville, South Carolina, 29607, United States
Local Institution - 0515
Knoxville, Tennessee, 37920, United States
Local Institution - 0433
Dallas, Texas, 75390, United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Local Institution - 0377
The Woodlands, Texas, 77380, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Local Institution - 0131
Fairfax, Virginia, 22031, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Local Institution - 0465
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Local Institution - 0568
Lujan de Cuyo, Mendoza Province, 5509, Argentina
Local Institution - 0463
Rosario, Santa Fe Province, 2000, Argentina
Local Institution - 0618
Rosario, Santa Fe Province, 2000, Argentina
Centro Oncologico Korben
Buenos Aires, 1426, Argentina
Local Institution - 0472
Buenos Aires, C1199ABB, Argentina
Local Institution - 0446
Buenos Aires, C1280AEB, Argentina
Local Institution - 0432
Liverpool, New South Wales, 2170, Australia
Local Institution - 0591
St Leonards, New South Wales, 2065, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Grampians Health
Ballarat Central, Victoria, 3350, Australia
Local Institution - 0368
Garran, ACT 2605, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, 4020, Austria
Landeskrankenhaus Rankweil
Rankweil, 6830, Austria
Local Institution - 0207
Vienna, 1210, Austria
Antwerp University Hospital
Edegem, Antwerpen, 2650, Belgium
Local Institution - 0225
Yvoir, Namur, 5530, Belgium
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800, Belgium
UZ Brussel
Brussels, 1090, Belgium
Local Institution - 0340
Liège, 4000, Belgium
Local Institution - 0077
Fortaleza, Ceará, 60810180, Brazil
CEDOES
Vitória, Espírito Santo, 29055450, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59062-000, Brazil
Local Institution - 0576
Porto Alegre, Rio Grande do Sul, 90560-003, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Local Institution - 0080
Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, 14784400, Brazil
NAIC - Instituto do Câncer
Bauru, São Paulo, 17033-490, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13060-803, Brazil
Local Institution - 0355
São Caetano do Sul, São Paulo, 09541-270, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090000, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, 01509-010, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20231-050, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000, Brazil
Local Institution - 0315
Panagyurishte, Pazardzhik, 4500, Bulgaria
Local Institution - 0459
Sofia, Sofia, 1431, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300, Bulgaria
Complex Oncology Center - Ruse EOOD
Rousse, 7002, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, 1527, Bulgaria
Trakia Hospital
Stara Zagora, 6000, Bulgaria
Local Institution - 0473
Providencia, Santiago Metropolitan, 7500713, Chile
Local Institution - 0476
Recoleta, Santiago Metropolitan, 8420000, Chile
Local Institution - 0566
Antofagasta, 1240000, Chile
Local Institution - 0475
Santiago, 8330015, Chile
Local Institution - 0072
Hefei, Anhui, 230031, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100034, China
Local Institution - 0049
Beijing, Beijing Municipality, 100142, China
Local Institution - 0286
Beijing, Beijing Municipality, 100142, China
Local Institution - 0621
Beijing, Beijing Municipality, 101149, China
Local Institution - 0108
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 0, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
Local Institution - 0061
Guangzhou, Guangdong, 510515, China
Local Institution - 0281
Shenzhen, Guangdong, 518020, China
Guangxi Medical University Affiliated Cancer Hospital
Nanning, Guangxi, 530021, China
Local Institution - 0408
Guiyang, Guizhou, 550002, China
Local Institution - 0353
Shijiazhuang, Hebei, 050035, China
Local Institution - 0106
Harbin, Heilongjiang, 150081, China
Local Institution - 0107
Zhengzhou, Henan, 450000, China
Local Institution - 0047
Zhengzhou, Henan, 450008, China
Wuhan Union Hospital Cancer Center
Wuhan, Hubei, 430023, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Local Institution - 0057
Changsha, Hunan, 0, China
Local Institution - 0387
Changsha, Hunan, 410008, China
Local Institution - 0050
Changsha, Hunan, 410013, China
Local Institution - 0352
Nanjing, Jiangsu, 210000, China
Local Institution - 0279
Nanjing, Jiangsu, 210009, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
The First affiliated hospital of Nanchang University (Xianghu campus)
Nanchang, Jiangxi, 330209, China
Local Institution - 0075
Changchun, Jilin, 132000, China
Local Institution - 0284
Shenyang, Liaoning, 110001, China
Local Institution - 0104
Shenyang, Liaoning, 110004, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
Xi'an, Shaanxi, 710038, China
Local Institution - 0051
Jinan, Shandong, 250117, China
LinYi Cancer Hospital
Linyi, Shandong, 276001, China
Local Institution - 0068
Qingdao, Shandong, 266003, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0283
Taiyuan, Shanxi, 030000, China
Sichuan Cancer hospital
Chengdu, Sichuan, 610041, China
West China Hospital Sichuan University
Chengdu, Sichuan, 611135, China
Local Institution - 0280
Hangzhou, Zhejiang, 310003, China
Local Institution - 0069
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Local Institution - 0330
Medellín, Antioquia, 050030, Colombia
Local Institution - 0305
Bogotá, Cundinamarca, 111511, Colombia
Local Institution - 0306
Montería, Departamento de Córdoba, 230002, Colombia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05, Czechia
Local Institution - 0614
Ostrava, Ostrava Město, 70384, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Local Institution - 0356
Copenhagen, Capital Region, 2100, Denmark
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600, France
Centre François Baclesse
Caen, Calvados, 14076, France
Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079, France
Chu Jean Minjoz
Besançon, Doubs, 25000, France
CHRU de Brest
Brest, Finistère, 29200, France
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-Garonne, 31059, France
Local Institution - 0220
Montpellier, Hérault, 34298, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033, France
Local Institution - 0215
Saint-Herblain, Loire-Atlantique, 44800, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
Chu Gabriel Montpied
Clermont-Ferrand, Puy-de-Dôme, 63000, France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, Rhône, 69677, France
Local Institution - 0213
Créteil, Val-de-Marne, 94010, France
Local Institution - 0599
Villejuif, Val-De-Marne, 94805, France
Local Institution - 0583
Nice, 51069-06001, France
Institut Curie
Paris, 75248, France
Local Institution - 0586
Reims, 51100, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, 37032, France
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, 75014, France
Local Institution - 0461
Göppingen, Baden-Wurttemberg, 73035, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Baden-Wurttemberg, 70376, Germany
Local Institution - 0580
Tübingen, Baden-Wurttemberg, 72076, Germany
Bundeswehrkrankenhaus Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Local Institution - 0617
Donauwörth, Bavaria, 86609, Germany
Local Institution - 0202
München, Bavaria, 81675, Germany
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, 93049, Germany
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121, Germany
Local Institution - 0551
Bonn, North Rhine-Westphalia, 53127, Germany
Local Institution - 0582
Hemer, North Rhine-Westphalia, 58675, Germany
Local Institution - 0198
Berlin, 14165, Germany
LungenClinic Grosshansdorf
Großhansdorf, 22927, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Klinik Löwenstein
Löwenstein, 74245, Germany
University Hospital of Patras
Pátrai, Achaḯa, 26504, Greece
Errikos Dunant Hospital Center
Athens, Attikí, 115 26, Greece
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, 115 27, Greece
Alexandra General Hospital of Athens
Athens, Attikí, 115 28, Greece
Local Institution - 0006
Thessaloniki, Kentrikí Makedonía, 540 07, Greece
Local Institution - 0585
Marousi, North Athens, 15123, Greece
University General Hospital of Larissa
Larissa, Thessalía, 41110, Greece
Local Institution - 0481
Thessaloniki, 57001, Greece
Queen Mary Hospital
Hksar, 0, Hong Kong
Local Institution - 0323
Shatin, 0, Hong Kong
Local Institution - 0290
Gyula, Bekes County, 5700, Hungary
Local Institution - 0291
Gyöngyös, Heves County, 3200, Hungary
Farkasgyepui Tudogyogyintezet
Farkasgyepű, Veszprém megye, 8582, Hungary
Local Institution - 0288
Budapest, 1083, Hungary
Local Institution - 0263
Bangalore, Karnataka, 560092, India
Local Institution - 0344
Bengaluru, Karnataka, 560017, India
Local Institution - 0345
Mumbai, Maharashtra, 400004, India
Local Institution - 0266
Mumbai, Maharashtra, 400012, India
Local Institution - 0620
Nashik, Maharashtra, 422009, India
Local Institution - 0267
New Delhi, National Capital Territory of Delhi, 110029, India
Local Institution - 0265
Hyderabad, Telangana, 500033, India
Local Institution - 0264
Varanasi, Uttar Pradesh, 221002, India
Local Institution - 0010
Kfar Saba, Central District, 4428164, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Local Institution - 0017
Jerusalem, Jerusalem, 9013102, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Local Institution - 0016
Afula, Northern District, 1834111, Israel
Rambam Health Care Campus
Haifa, Northern District, 3109601, Israel
Local Institution - 0546
Beersheba, 84801, Israel
AOU della Campania Luigi Vanvitelli
Naples, Campania, 80131, Italy
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna, 48121, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043, Italy
Local Institution - 0485
Candiolo, Turin, 10060, Italy
Local Institution - 0486
Siena, Tuscany, 53100, Italy
AO Santa Maria della Misericordia
Perugia, Umbria, 06132, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Local Institution - 0483
Rome, 152, Italy
Local Institution - 0468
Verona, 37126, Italy
Local Institution - 0243
Nagoya, Aichi-ken, 460-0001, Japan
Local Institution - 0334
Otashi, Gunma, 373-8550, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648, Japan
Local Institution - 0336
Himeji, Hyōgo, 670-8520, Japan
Local Institution - 0247
Kobe, Hyōgo, 650-0047, Japan
Local Institution - 0335
Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan
Local Institution - 0257
Kawasaki, Kanagawa, 216-8511, Japan
Local Institution - 0238
Yokohama, Kanagawa, 2418515, Japan
Local Institution - 0241
Nankoku, Kochi, 783-8505, Japan
Local Institution - 0237
Matsusaka, Mie-ken, 515-8544, Japan
Local Institution - 0232
Sendai, Miyagi, 9810914, Japan
Local Institution - 0240
Hirakata, Osaka, 573-1191, Japan
Local Institution - 0245
Hidaka, Saitama, 350-1298, Japan
Local Institution - 0235
Shimotsuga, Tochigi, 321-0293, Japan
Local Institution - 0234
Bunkyo-ku, Tokyo, 1138603, Japan
Local Institution - 0242
Ube, Yamaguchi, 755-0241, Japan
Local Institution - 0246
Fukuoka, 811-1395, Japan
Local Institution - 0244
Okayama, 701-1192, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Local Institution - 0413
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Local Institution - 0390
Kuching, Sarawak, 93590, Malaysia
Local Institution - 0296
Guadalajara, Jalisco, 44260, Mexico
Local Institution - 0326
Guadalajara, Jalisco, 44680, Mexico
Local Institution - 0293
Mexico City, Mexico City, 03100, Mexico
Local Institution - 0294
Mexico City, Mexico City, 06760, Mexico
Local Institution - 0298
Monterrey, Nuevo León, 66460, Mexico
Local Institution - 0297
Oaxaca City, Oaxaca, 68020, Mexico
Local Institution - 0327
Chihuahua City, 31203, Mexico
Local Institution - 0331
Puebla City, 72530, Mexico
Local Institution - 0328
Querétaro, 76000, Mexico
Local Institution - 0574
Heerlen, Limburg, 6419PC, Netherlands
Local Institution - 0445
Veldhoven, North Brabant, 5504 DB, Netherlands
Local Institution - 0230
Arnhem, 6815 AD, Netherlands
University Medical Center Groningen
Groningen, 9713 GZ, Netherlands
Local Institution - 0096
Drammen, Buskerud, 3004, Norway
Local Institution - 0604
Elverum, Innlandet, 2418, Norway
Local Institution - 0603
Oslo, 450, Norway
Centrum Medyczne Pratia Poznań
Poznan, Greater Poland Voivodeship, 60-192, Poland
Local Institution - 0259
Krakow, Lesser Poland Voivodeship, 30-727, Poland
Local Institution - 0612
Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
Local Institution - 0594
Warsaw, Masovian Voivodeship, 02-781, Poland
Local Institution - 0261
Warsaw, Masovian Voivodeship, 04-125, Poland
Local Institution - 0458
Wieliszew, Masovian Voivodeship, 05-135, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Pomeranian Voivodeship, 82-550, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
Bydgoszcz, 85796, Poland
Local Institution - 0607
Oradea, Bihor County, 410469, Romania
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, Bucharest, 022338, Romania
Local Institution - 0619
Cluj-Napoca, Cluj, 400001, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, 407280, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542, Romania
Radiology Therapeutic Center
Otopeni, Ilfov, 075100, Romania
Centrul de Diagnostic si Tratament Provita
Bucharest, 020335, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106, Romania
Institutul Regional de Oncologie
Iași, 700483, Romania
Spitalul Municipal Schuller Ploiești
Ploieşti, 100337, Romania
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
Local Institution - 0571
Suwon, Kyǒnggi-do, 16499, South Korea
Local Institution - 0270
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], 03722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 0573
Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
Local Institution - 0471
Seoul, 06591, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0248
Hospitalet, Barcelona [Barcelona], 08907, Spain
Local Institution - 0253
Barcelona, Catalunya [Cataluña], 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Comunidad de, 28222, Spain
Local Institution - 0480
Madrid, 28046, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Local Institution - 0255
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Chi Mei Hospital - Liouying Branch
Tainan, Tainan, 73657, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Local Institution - 0411
Bangkok, 10330, Thailand
Local Institution - 0412
Bangkok, 10700, Thailand
Local Institution - 0349
Izmir, Karsiyaka, İzmir, 009035575, Turkey (Türkiye)
Local Institution - 0318
Adana, 01140, Turkey (Türkiye)
Local Institution - 0317
Adana, 01370, Turkey (Türkiye)
Local Institution - 0321
Ankara, 06680, Turkey (Türkiye)
Local Institution - 0593
Ankara, 06800, Turkey (Türkiye)
Local Institution - 0350
Antalya, 07059, Turkey (Türkiye)
Local Institution - 0320
Bursa, 16059, Turkey (Türkiye)
Local Institution - 0319
Edirne, 22030, Turkey (Türkiye)
Local Institution - 0595
Istanbul, 34854, Turkey (Türkiye)
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW, United Kingdom
Sarah Cannon Research Institute UK
London, London, City of, w1g 6ad, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The Phase 2 portion of this study will be blinded to sites, participants, investigators, and certain site-facing members of the Sponsor. The Phase 3 portion of this study will be blinded to participants, investigators, and the Sponsor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 14, 2025
Study Start
January 2, 2026
Primary Completion (Estimated)
August 12, 2031
Study Completion (Estimated)
August 12, 2031
Last Updated
June 5, 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
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