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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Colorectal Cancer; Advanced Colorectal Cancer
• Intervention / Treatment: Drug: MRTX849; Biological: Cetuximab; Drug: mFOLFOX6 Regimen; Drug: FOLFIRI Regimen

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRTX849 + Cetuximab	Drug: MRTX849; 28 Day Cycle; Biological: Cetuximab; 28 Day Cycle; Other Names: Erbitux
Active Comparator: mFOLFOX6 or FOLFIRI	Drug: mFOLFOX6 Regimen; Fluorouracil; Oxaliplatin; Folinic acid; Drug: FOLFIRI Regimen; Fluorouracil; Irinotecan; Folinic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Defined as time from randomization until disease progression or death from any cause, whichever occurs first.	30 months
Overall Survival (OS)	Defined as time from date of randomization to date of death due to any cause.	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.	30 months
Adverse Events	Defined as number of patients with treatment emergent AEs.	30 months
Objective Response Rate (ORR)	Defined as the percent of patients documented to have a confirmed CR or PR.	30 months
Patient Reported Outcomes (PROs)	To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).	30 months
Quality of Life Assessment	To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).	30 months

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): January 16, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal Cancer; KRAS G12C; Rectal Cancer; Colon Cancer; Colorectal Carcinoma; KRAS; RAS; Colorectal Adenocarcinoma; Colorectal Cancer Trial
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab; adagrasib
• Other Study ID Numbers: CA239-0006 (Other Identifier: Bristol-Myers Squibb Protocol ID); 849-010 (Other Identifier: Mirati Therapeutics Protocol ID); KRYSTAL-10 (Other Identifier: Mirati Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No