Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy
3 other identifiers
interventional
461
31 countries
416
Brief Summary
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2021
Longer than P75 for phase_3
416 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
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedApril 27, 2026
April 1, 2026
4.5 years
March 2, 2021
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
Defined as time from date of randomization to date of death due to any cause.
30 months
Progression-free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
30 months
Secondary Outcomes (5)
Adverse Events
30 months
Objective Response Rate (ORR)
30 months
Duration of Response (DOR)
30 months
Patient Reported Outcomes (PROs)
30 months
Quality of Life Assessment
30 months
Study Arms (2)
MRTX849 + Cetuximab
EXPERIMENTALmFOLFOX6 or FOLFIRI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
- Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.
You may not qualify if:
- Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
- Active brain metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (419)
Local Institution - 010-855-E
Alabaster, Alabama, 35007, United States
Local Institution - 010-855-B
Bessemer, Alabama, 35022, United States
Local Institution - 010-855-D
Birmingham, Alabama, 35209, United States
Local Institution - 010-855-A
Birmingham, Alabama, 35211, United States
Local Institution - 010-855-F
Birmingham, Alabama, 35235, United States
Local Institution - 010-855-C
Birmingham, Alabama, 35243, United States
Local Institution - 010-855
Birmingham, Alabama, 35243, United States
Local Institution - 010-996
Gilbert, Arizona, 85234, United States
Local Institution - 010-566
Goodyear, Arizona, 85338, United States
Local Institution - 010-989
Phoenix, Arizona, 85054, United States
Local Institution - 010-978
Springdale, Arkansas, 72762, United States
Local Institution - 010-573
Bakersfield, California, 93309, United States
Local Institution - 010-979C
Chula Vista, California, 91911, United States
Local Institution - 010-980
Fresno, California, 93701, United States
Local Institution - 010-851
Fullerton, California, 92835, United States
Local Institution - 010-979A
La Mesa, California, 91942, United States
Local Institution - 010-958A
Los Angeles, California, 90033, United States
Local Institution - 010-958
Los Angeles, California, 90033, United States
Local Institution - 010-551
Los Angeles, California, 90048, United States
Local Institution - 010-847
Newport Beach, California, 92663, United States
Local Institution - 010-563
Redlands, California, 92373, United States
Local Institution - 010-979B
San Diego, California, 92123, United States
Local Institution - 010-979D
San Diego, California, 92123, United States
Local Institution - 010-979
San Diego, California, 92123, United States
Local Institution - 010-982
San Francisco, California, 94115, United States
Local Institution - 010-561
Santa Monica, California, 90404, United States
Local Institution - 010-571
Sylmar, California, 91342, United States
Local Institution - 010-574
Torrance, California, 90505, United States
Local Institution - 010-570
Whittier, California, 90602, United States
Local Institution - 010-872-H
Aurora, Colorado, 80012, United States
Local Institution - 010-810
Aurora, Colorado, 80045, United States
Local Institution - 010-872-A
Boulder, Colorado, 80303, United States
Local Institution - 010-872-E
Centennial, Colorado, 80112, United States
Local Institution - 010-872-C
Colorado Springs, Colorado, 80907, United States
Local Institution - 010-872
Denver, Colorado, 80218, United States
Local Institution - 010-872-B
Denver, Colorado, 80220, United States
Local Institution - 010-872-J
Lakewood, Colorado, 80228, United States
Local Institution - 010-872-F
Littleton, Colorado, 80218, United States
Local Institution - 010-872-G
Longmont, Colorado, 80501, United States
Local Institution - 010-872-I
Pueblo, Colorado, 81008, United States
Local Institution - 010-872-D
Thornton, Colorado, 80260, United States
Local Institution - 010-949
Norwich, Connecticut, 06360, United States
Local Institution - 010-922-A
Bonita Springs, Florida, 34135, United States
Local Institution - 010-922-D
Bradenton, Florida, 34211, United States
Local Institution - 010-922-E
Cape Coral, Florida, 33909, United States
Local Institution - 010-922
Fort Myers, Florida, 33901, United States
Local Institution - 010-922-B
Fort Myers, Florida, 33905, United States
Local Institution - 010-922-C
Fort Myers, Florida, 33908, United States
Local Institution - 010-984-B
Holiday, Florida, 34691, United States
Local Institution - 010-829
Jacksonville, Florida, 32224, United States
Local Institution - 010-923-A
Largo, Florida, 33770, United States
Local Institution - 010-923-B
Largo, Florida, 33770, United States
Local Institution - 010-923-C
Largo, Florida, 33770, United States
Local Institution - 010-923-D
Largo, Florida, 33770, United States
Local Institution - 010-923-E
Largo, Florida, 33770, United States
Local Institution - 010-923-F
Largo, Florida, 33770, United States
Local Institution - 010-923-G
Largo, Florida, 33770, United States
Local Institution - 010-923-H
Largo, Florida, 33770, United States
Local Institution - 010-923-I
Largo, Florida, 33770, United States
Local Institution - 010-923-J
Largo, Florida, 33770, United States
Local Institution - 010-923-K
Largo, Florida, 33770, United States
Local Institution - 010-923-L
Largo, Florida, 33770, United States
Local Institution - 010-923-M
Largo, Florida, 33770, United States
Local Institution - 010-923-N
Largo, Florida, 33770, United States
Local Institution - 010-923-O
Largo, Florida, 33770, United States
Local Institution - 010-923-P
Largo, Florida, 33770, United States
Local Institution - 010-990
Miami, Florida, 33136, United States
Local Institution - 010-922-F
Naples, Florida, 34102, United States
Local Institution - 010-922-G
Naples, Florida, 34102, United States
Local Institution - 010-538
Ocala, Florida, 34474, United States
Local Institution - 010-896
Orlando, Florida, 32804, United States
Local Institution - 010-988
Orlando, Florida, 32806, United States
Local Institution - 010-922-H
Port Charlotte, Florida, 33980, United States
Local Institution - 010-923
St. Petersburg, Florida, 33705, United States
Local Institution - 010-984
St. Petersburg, Florida, 33709-2236, United States
Local Institution - 010-924
Tallahassee, Florida, 32308, United States
Local Institution - 010-984-A
Trinity, Florida, 34655, United States
Local Institution - 010-926
West Palm Beach, Florida, 33401, United States
Local Institution - 010-537
Weston, Florida, 33331, United States
Local Institution - 010-956
Atlanta, Georgia, 30322, United States
Local Institution - 010-986
Newnan, Georgia, 30265, United States
Local Institution - 010-963
Naperville, Illinois, 60540, United States
Local Institution - 010-994
Zion, Illinois, 60099, United States
Local Institution - 010-569-A
Indianapolis, Indiana, 46237-8601, United States
Local Institution - 010-569
Indianapolis, Indiana, 46237-8601, United States
Local Institution - 010-991
Iowa City, Iowa, 52242, United States
Local Institution - 010-920
Baton Rouge, Louisiana, 70809, United States
Local Institution - 010-534
Baltimore, Maryland, 21201, United States
Local Institution - 010-997
Boston, Massachusetts, 02215, United States
Local Institution - 010-531A
Brownstown, Michigan, 48183, United States
Local Institution - 010-531C
Dearborn, Michigan, 48126, United States
Local Institution - 010-531
Detroit, Michigan, 48202, United States
Local Institution - 010-531B
Novi, Michigan, 48377, United States
Local Institution - 010-875
Minneapolis, Minnesota, 55404, United States
Local Institution - 010-830
Rochester, Minnesota, 55905, United States
Local Institution - 010-838
Saint Louis Park, Minnesota, 55416, United States
Local Institution - 010-838A
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838B
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838C
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838D
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838E
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838F
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838G
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838H
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838I
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838J
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838K
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838L
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-838M
Saint Louis Park, Minnesota, 55426, United States
Local Institution - 010-541
Springfield, Missouri, 65804, United States
Local Institution - 010-564
Lincoln, Nebraska, 68510, United States
Local Institution - 010-590
Omaha, Nebraska, 68130, United States
Local Institution - 010-860 - A
Henderson, Nevada, 89052, United States
Local Institution - 010-860-F
Henderson, Nevada, 89052, United States
Local Institution - 010-860-B
Henderson, Nevada, 89074, United States
Local Institution - 010-860-D
Las Vegas, Nevada, 89128, United States
Local Institution - 010-860-C
Las Vegas, Nevada, 89144, United States
Local Institution - 010-860-E
Las Vegas, Nevada, 89148, United States
Local Institution - 010-860
Las Vegas, Nevada, 89169, United States
Local Institution - 010-918 - B
Basking Ridge, New Jersey, 07920, United States
Local Institution - 010-993
Belleville, New Jersey, 07109, United States
Local Institution - 010-975
East Brunswick, New Jersey, 08816, United States
Local Institution - 010-992
Florham Park, New Jersey, 07932, United States
Local Institution - 010-918 - D
Middletown, New Jersey, 07748, United States
Local Institution - 010-918 - C
Montvale, New Jersey, 07645, United States
Local Institution - 010-957
New Brunswick, New Jersey, 08903-2681, United States
Local Institution - 010-535 - D
Babylon, New York, 11702, United States
Local Institution - 010-918 - A
Commack, New York, 11725, United States
Local Institution - 010-918 - F
Harrison, New York, 10604, United States
Local Institution - 010-813
New York, New York, 10016, United States
Local Institution - 010-535 - G
New York, New York, 10028, United States
Local Institution - 010-998
New York, New York, 10029, United States
Local Institution - 010-918
New York, New York, 10065, United States
Local Institution - 010-535 - C
Patchogue, New York, 11772, United States
Local Institution - 010-535 - A
Port Jefferson, New York, 11776, United States
Local Institution - 010-535 - B
Port Jefferson Station, New York, 11776, United States
Local Institution - 010-535 - F
Riverhead, New York, 11901, United States
Local Institution - 010-535
Shirley, New York, 11967, United States
Local Institution - 010-535 - E
The Bronx, New York, 10469, United States
Local Institution - 010-918 - E
Uniondale, New York, 11553, United States
Local Institution - 010-585-B
Clinton, North Carolina, 28328, United States
Local Institution - 010-585
Goldsboro, North Carolina, 27534, United States
Local Institution - 010-585-A
Jacksonville, North Carolina, 28546, United States
Local Institution - 010-893
Cincinnati, Ohio, 45211, United States
Local Institution - 010-532
Oklahoma City, Oklahoma, 73104, United States
Local Institution - 010-549
Oklahoma City, Oklahoma, 73120, United States
Local Institution - 010-584
Tulsa, Oklahoma, 74146, United States
Local Institution - 010-596
Pittsburgh, Pennsylvania, 15212, United States
Local Institution - 010-981
Greenville, South Carolina, 29607, United States
Local Institution - 010-921
Chattanooga, Tennessee, 37404, United States
Local Institution - 010-801
Nashville, Tennessee, 37203, United States
Local Institution - 010-572
Dallas, Texas, 75216, United States
Local Institution - 010-879
Dallas, Texas, 75246, United States
Local Institution - 010-577-B
Houston, Texas, 77008, United States
Local Institution - 010-577-A
Houston, Texas, 77024, United States
Local Institution - 010-577
Houston, Texas, 77030, United States
Local Institution - 010-848
Houston, Texas, 77030, United States
Local Institution - 010-977
Houston, Texas, 77090, United States
Local Institution - 010-999
Irving, Texas, 75063, United States
Local Institution - 010-878-B
Longview, Texas, 75601, United States
Local Institution - 010-862
San Antonio, Texas, 78240, United States
Local Institution - 010-964
Temple, Texas, 76508, United States
Local Institution - 010-878
Tyler, Texas, 75702, United States
Local Institution - 010-976-F
American Fork, Utah, 84003, United States
Local Institution - 010-976-C
Bountiful, Utah, 84010, United States
Local Institution - 010-976-D
Layton, Utah, 84041, United States
Local Institution - 010-976-A
Murray, Utah, 84157, United States
Local Institution - 010-976-H
Ogden, Utah, 84405, United States
Local Institution - 010-976-G
Provo, Utah, 84604, United States
Local Institution - 010-976-B
Salt Lake City, Utah, 84102, United States
Local Institution - 010-976
Salt Lake City, Utah, 84106, United States
Local Institution - 010-976-E
West Jordan, Utah, 84088, United States
Local Institution - 010-919
Fairfax, Virginia, 22031-4630, United States
Local Institution - 010-597
Fredericksburg, Virginia, 24408, United States
Local Institution - 010-539
Richmond, Virginia, 23229, United States
Local Institution - 010-536
Richmond, Virginia, 23298, United States
Local Institution - 010-533 A
Auburn, Washington, 98001, United States
Local Institution - 010-576
Everett, Washington, 98201, United States
Local Institution - 010-533 B
Gig Harbor, Washington, 98335, United States
Local Institution - 010-533 C
Puyallup, Washington, 98372, United States
Local Institution - 010-824
Seattle, Washington, 98109--1023, United States
Local Institution - 010-533
Tacoma, Washington, 98405, United States
Local Institution - 010-885
Vancouver, Washington, 98684, United States
Local Institution - 010-575
Morgantown, West Virginia, 26506-9300, United States
Local Institution - 010-947
Milwaukee, Wisconsin, 53226, United States
Local Institution - 010-434
Buenos Aires, C1426ANZ, Argentina
Local Institution - 010-431
Buenos Aires, CI264 AAA, Argentina
Local Institution - 010-432
CABA, 1061, Argentina
Local Institution - 010-430
La Rioja, F5300COE, Argentina
Local Institution - 010-448
Porto Alegre, 91350-200, Argentina
Local Institution - 010-433
Viedma, R8500ACE, Argentina
Local Institution - 010-005
Bedford Park, 5042, Australia
Local Institution - 010-004
Clayton, 3168, Australia
Local Institution - 010-006
Garran, 2065, Australia
Local Institution - 010-015
Heidelberg, 3084, Australia
Local Institution - 010-012
Melbourne, 3004, Australia
Local Institution - 010-002
Waratah, 2298, Australia
Local Institution - 010-145
Innsbruck, 6020, Austria
Local Institution - 010-144
Vienna, 1090, Austria
Local Institution - 010-143
Wiener Neustadt, 2700, Austria
Local Institution - 010-154
Brussels, 1090, Belgium
Local Institution - 010-157
Edegem, 2650, Belgium
Local Institution - 010-156
Ghent, 9000, Belgium
Local Institution - 010-150
Yvoir, B-5530, Belgium
Local Institution - 010-446
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Local Institution - 010-443
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution - 010-450
Blumenau, Santa Catarina, 89010-340, Brazil
Local Institution - 010-442
Curitiba, 80040-170, Brazil
Local Institution - 010-449
Liberdade, 01509-010, Brazil
Local Institution - 010-444
Santo André, 09060-650, Brazil
Local Institution - 010-440
São José do Rio Preto, 15090-000, Brazil
Local Institution - 010-441
São Paulo, 01246-000, Brazil
Local Institution - 010-445
São Paulo, 01323-030, Brazil
Local Institution - 010-447
São Paulo, 04543-000, Brazil
Local Institution - 010-481
Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 010-483
Toronto, Ontario, M5B 1W8, Canada
Local Institution - 010-482
Toronto, Ontario, M5G 2M9, Canada
Local Institution - 010-487
Montreal, Quebec, H1T 2M4, Canada
Local Institution - 010-712
Bengbu, Anhui, 233004, China
Local Institution - 010-026
Hefei, Anhui, 230001, China
Local Institution - 010-022
Hefei, Anhui, 230022, China
Local Institution - 010-711
Hefei, Anhui, 230031, China
Local Institution - 010-717
Beijing, Beijing Municipality, 100021, China
Local Institution - 010-029
Fuzhou, Fujian, 350014, China
Local Institution - 010-031
Guangzhou, Guangdong, 510655, China
Local Institution - 010-713
Shenzhen, Guangdong, 518036, China
Local Institution - 010-715
Nanning, Guangxi, 530021, China
Local Institution - 010-021
Zhengzhou, Henan, 450008, China
Local Institution - 010-703
Wuhan, Hubei, 430030, China
Local Institution - 010-701
Wuhan, Hubei, 430079, China
Local Institution - 010-035
Changsha, Hunan, 410008, China
Local Institution - 010-714
Jiangyin, Jiangsu, 214400, China
Local Institution - 010-704
Nanjing, Jiangsu, 210029, China
Local Institution - 010-706
Nanchang, Jiangxi, 330006, China
Local Institution - 010-030
Changchun, Jilin, 130012, China
Local Institution - 010-718
Changchun, Jilin, 130021, China
Local Institution - 010-709
Shenyang, Liaoning, 110001, China
Local Institution - 010-705
Shenyang, Liaoning, 110042, China
Local Institution - 010-036
Jinan, Shandong, 250117, China
Local Institution - 010-038
Shanghai, Shanghai Municipality, 200080, China
Local Institution - 010-020
Shanghai, Shanghai Municipality, 200120, China
Local Institution - 010-708
Shanghai, Shanghai Municipality, 200240, China
Local Institution - 010-025
Shanghai Shi, Shanghai Municipality, 200025, China
Local Institution - 010-024
Shanghaishi, Shanghai Municipality, 200032, China
Local Institution - 010-710
Chengdu, Sichuan, 610044, China
Local Institution - 010-716
Neijiang, Sichuan, 641199, China
Local Institution - 010-027
Tianjin, Tianjin Municipality, 300060, China
Local Institution - 010-707
Hangzhou, Zhejiang, 310009, China
Local Institution - 010-034
Hangzhou, Zhejiang, 310022, China
Local Institution - 010-032
Hangzhou, 310016, China
Local Institution - 010-033
Hongkou Qu, 200080, China
Local Institution - 010-460
Barranquilla, 080020, Colombia
Local Institution - 010-462
Bogotá, 0, Colombia
Local Institution - 010-465
Floridablanca, 0, Colombia
Local Institution - 010-463
Medellín, 050034, Colombia
Local Institution - 010-165
Brno, 656 53, Czechia
Local Institution - 010-160
Brno, 656 91, Czechia
Local Institution - 010-162
Olomouc, 779 00, Czechia
Local Institution - 010-161
Prague, 150 06, Czechia
Local Institution - 010-171
Copenhagen, 2100, Denmark
Local Institution - 010-172
Odense, 5000, Denmark
Local Institution - 010-170
Vejle, 7100, Denmark
Local Institution - 010-180
Helsinki, FI-00029, Finland
Local Institution - 010-182
Tampere, 33520, Finland
Local Institution - 010-181
Turku, 20521, Finland
Local Institution - 010-209-A
Chambray-lès-Tours, Centre-Val de Loire, 37170, France
Local Institution - 010-668
Avignon, 84918, France
Local Institution - 010-208
Besançon, 25000, France
Local Institution - 010-669
Bordeaux, 33000, France
Local Institution - 010-194
Brest, 29200, France
Local Institution - 010-192
Dijon, 21079, France
Local Institution - 010-662
Lille, 59037, France
Local Institution - 010-205
Lyon, 69008, France
Local Institution - 010-682
Marseille, 13005, France
Local Institution - 010-207
Paris, 75010, France
Local Institution - 010-203
Paris, 75012, France
Local Institution - 010-204
Paris, 75013, France
Local Institution - 010-661
Paris, 75015, France
Local Institution - 010-660
Pessac, 33720, France
Local Institution - 010-667
Suresnes, 92150, France
Local Institution - 010-680
Toulouse, 31059, France
Local Institution - 010-209
Tours, 37044, France
Local Institution - 010-202
Villejuif, 94805, France
Local Institution - 010-675
Amberg, 92224, Germany
Local Institution - 010-657
Berlin, 10117, Germany
Local Institution - 010-655
Bochum, 44791, Germany
Local Institution - 010-227
Dresden, 01307, Germany
Local Institution - 010-229
Frankfurt am Main, 60488, Germany
Local Institution - 010-656
Hamburg, D-20249, Germany
Local Institution - 010-658
Herne, 44625, Germany
Local Institution - 010-228
Mönchengladbach, 41063, Germany
Local Institution - 010-650
München, 81377, Germany
Local Institution - 010-226
München, 81737, Germany
Local Institution - 010-652
Reutlingen, 72764, Germany
Local Institution - 010-676
Ulm, 89081, Germany
Local Institution - 010-501
Athens, 11528, Greece
Local Institution - 010-232
Cholargós, 155 62, Greece
Local Institution - 010-238
Heraklion, 71110, Greece
Local Institution - 010-235
Larissa, 41110, Greece
Local Institution - 010-231
Thessaloniki, 54645, Greece
Local Institution - 010-230
Thessaloniki, 57001, Greece
Local Institution - 010-048
Central, 0, Hong Kong
Local Institution - 010-046
Hong Kong, 0, Hong Kong
Local Institution - 010-250
Dublin, 4, Ireland
Local Institution - 010-252
Dublin, 9, Ireland
Local Institution - 010-253
Dublin, D07 R2WY, Ireland
Local Institution - 010-254
Dublin, D07 WKW8, Ireland
Local Institution - 010-251
Dublin, D24 NR0A, Ireland
Local Institution - 010-292
Avellino, 83100, Italy
Local Institution - 010-290
Biella, 13875, Italy
Local Institution - 010-299
Cagliari, 9042, Italy
Local Institution - 010-286
Candiolo, 10060, Italy
Local Institution - 010-287
Lido di Camaiore, 55041, Italy
Local Institution - 010-270
Meldola, 47014, Italy
Local Institution - 010-278
Milan, 20141, Italy
Local Institution - 010-293
Milan, 20162, Italy
Local Institution - 010-271
Naples, 80131, Italy
Local Institution - 010-297
Padova, 35128, Italy
Local Institution - 010-294
Pisa, 56126, Italy
Local Institution - 010-291
Reggio Emilia, 42100, Italy
Local Institution - 010-295
Roma, 00144, Italy
Local Institution - 010-289
Torino, 10128, Italy
Local Institution - 010-070
Johor Bahru, Johor, 81100, Malaysia
Local Institution - 010-077
Kota Kinabalu, Sabah, 88996, Malaysia
Local Institution - 010-071
Petaling Jaya, Selangor, 46050, Malaysia
Local Institution - 010-073
Kuala Lumpur, 50586, Malaysia
Local Institution - 010-074
Kuala Lumpur, 50603, Malaysia
Local Institution - 010-072
Putrajaya, 62250, Malaysia
Local Institution - 010-474
Tuxtla Gutiérrez, Chiapas, 29038, Mexico
Local Institution - 010-472
Guadalajara, Jalisco, 44280, Mexico
Local Institution - 010-477
Guadalajara, Jalisco, 44670, Mexico
Local Institution - 010-473
Mexico City, Mexico City, 14080, Mexico
Local Institution - 010-476
Cuernavaca, Morelos, 62290, Mexico
Local Institution - 010-475
San Juan del Río, Querétaro, 76800, Mexico
Local Institution - 010-471
Colonia Centro Orizaba, Veracruz, 94300, Mexico
Local Institution - 010-632
Amsterdam, 1066 CX, Netherlands
Local Institution - 010-306
Amsterdam, 1081 HV, Netherlands
Local Institution - 010-630
Nijmegen, 6525 GA, Netherlands
Local Institution - 010-307
Utrecht, 3543 AZ, Netherlands
Local Institution - 010-328
Gdansk, 80-219, Poland
Local Institution - 010-327
Otwock, 05-400, Poland
Local Institution - 010-322
Warsaw, 02-034, Poland
Local Institution - 010-787
Warsaw, 02-507, Poland
Local Institution - 010-332
Braga, 4710-243, Portugal
Local Institution - 010-337
Lisbon, 1400-038, Portugal
Local Institution - 010-640
Lisbon, 1649-035, Portugal
Local Institution - 010-331
Porto, 4099-001, Portugal
Local Institution - 010-339
Porto, 4200-072, Portugal
Local Institution - 010-902
San Juan, 00919, Puerto Rico
Local Institution - 010-903
San Juan, 00927, Puerto Rico
Local Institution - 010-900
San Juan, 00935, Puerto Rico
Local Institution - 010-347
Baia Mare, 430031, Romania
Local Institution - 010-349
Brasov, 500152, Romania
Local Institution - 010-512
Bucharest, 022328, Romania
Local Institution - 010-344
Cluj-Napoca, 400015, Romania
Local Institution - 010-340
Cluj-Napoca, 400641, Romania
Local Institution - 010-343
Craiova, 200746, Romania
Local Institution - 010-511
Ovidiu, 905900, Romania
Local Institution - 010-510
Timișoara, 300239, Romania
Local Institution - 010-090
Singapore, 119074, Singapore
Local Institution - 010-093
Singapore, 168583, Singapore
Local Institution - 010-095
Singapore, 188770, Singapore
Local Institution - 010-092
Singapore, 217562, Singapore
Local Institution - 010-091
Singapore, 258499, Singapore
Local Institution - 010-116
Anyang-si, 14068, South Korea
Local Institution - 010-111
Busan, 48108, South Korea
Local Institution - 010-119
Busan, 602-812, South Korea
Local Institution - 010-525
Daejeon, 35015, South Korea
Local Institution - 010-117
Goyang-si, 10408, South Korea
Local Institution - 010-100
Hwasun-gun, 58128, South Korea
Local Institution - 010-520
Seongnam-si, 13496, South Korea
Local Institution - 010-105
Seoul, 02841, South Korea
Local Institution - 010-108
Seoul, 03080, South Korea
Local Institution - 010-118
Seoul, 03722, South Korea
Local Institution - 010-104
Seoul, 05505, South Korea
Local Institution - 010-114
Seoul, 06351, South Korea
Local Institution - 010-109
Seoul, 06591, South Korea
Local Institution - 010-115
Suwon, 16247, South Korea
Local Institution - 010-524
Yangsan, 50612, South Korea
Local Institution - 010-613
A Coruña, 15006, Spain
Local Institution - 010-610
Badalona, 08916, Spain
Local Institution - 010-612
Barcelona, 08035, Spain
Local Institution - 010-600
Barcelona, 08036, Spain
Local Institution - 010-621
Córdoba, 14004, Spain
Local Institution - 010-620
LHospitalet de Llobregat, 08908, Spain
Local Institution - 010-619
Madrid, 28007, Spain
Local Institution - 010-601
Madrid, 28040, Spain
Local Institution - 010-617
Madrid, 28041, Spain
Local Institution - 010-624
Madrid, 28046, Spain
Local Institution - 010-623
Pamplona, 31008, Spain
Local Institution - 010-622
Sabadell, 08208, Spain
Local Institution - 010-604
Santander, 39008, Spain
Local Institution - 010-618
Valencia, 46010, Spain
Local Institution - 010-625
Valencia, 46014, Spain
Local Institution - 010-129
Changhua, 500, Taiwan
Local Institution - 010-121
Kaohsiung City, 807, Taiwan
Local Institution - 010-124
Taichung, 40705, Taiwan
Local Institution - 010-122
Tainan, 704, Taiwan
Local Institution - 010-123
Tainan, 73657, Taiwan
Local Institution - 010-120
Taipei, 10002, Taiwan
Local Institution - 010-125
Taoyuan District, 333, Taiwan
Local Institution - 010-132
Bang Phlat, 10700, Thailand
Local Institution - 010-134
Bangkok, 10400, Thailand
Local Institution - 010-131
Chiang Mai, 50200, Thailand
Local Institution - 010-130
Hat Yai, 90110, Thailand
Local Institution - 010-133
Khlong Toey, 10110, Thailand
Local Institution - 010-424
Sumy, 40022, Ukraine
Local Institution - 010-412
Aberdeen, AB25 2ZN, United Kingdom
Local Institution - 010-410
Birmingham, B15 2WB, United Kingdom
Local Institution - 010-413
Cambridge, CB2 0QQ, United Kingdom
Local Institution - 010-411
Dorset, BH7 7DW, United Kingdom
Local Institution - 010-400
Glasgow, G12 0XH, United Kingdom
Local Institution - 010-403
Kent, ME16 9QQ, United Kingdom
Local Institution - 010-414
Leeds, LS9 7TF, United Kingdom
Local Institution - 010-402
London, NW1 2BU, United Kingdom
Local Institution - 010-405
London, SW3 6JJ, United Kingdom
Local Institution - 010-406
London, SW3 6JJ, United Kingdom
Local Institution - 010-407
Manchester, M20 4BX, United Kingdom
Local Institution - 010-404
Middlesex, HA6 2RN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 11, 2021
Study Start
July 19, 2021
Primary Completion
January 16, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 27, 2026
Record last verified: 2026-04
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