Advanced Colorectal CancerPhase 3NCT04793958
Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)
A Phase 3 study testing MRTX849, Cetuximab and mFOLFOX6 Regimen in people with Advanced Colorectal Cancer and Metastatic Colorectal Cancer, run by Mirati Therapeutics Inc. at 419 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer, Metastatic Colorectal Cancer
- What is being tested?
- MRTX849, Cetuximab and mFOLFOX6 Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 419 sitesin 32 countries
- Study dates
- 24 Jun 2021to 23 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
419 sites in 32 countries.
419 sites in 32 countries
United States185 sites
Local Institution - 010-855-E
Alabaster, Alabama, 35007
Local Institution - 010-976-F
American Fork, Utah, 84003
Local Institution - 010-956
Atlanta, Georgia, 30322
Local Institution - 010-533 A
Auburn, Washington, 98001
Local Institution - 010-872-H
Aurora, Colorado, 80012
Local Institution - 010-810
Aurora, Colorado, 80045
Local Institution - 010-535 - D
Babylon, New York, 11702
Local Institution - 010-573
Bakersfield, California, 93309
Local Institution - 010-534
Baltimore, Maryland, 21201
Local Institution - 010-918 - B
Basking Ridge, New Jersey, 07920
Local Institution - 010-920
Baton Rouge, Louisiana, 70809
Local Institution - 010-993
Belleville, New Jersey, 07109
Local Institution - 010-855-B
Bessemer, Alabama, 35022
Local Institution - 010-855-D
Birmingham, Alabama, 35209
Local Institution - 010-855-A
Birmingham, Alabama, 35211
Local Institution - 010-855-F
Birmingham, Alabama, 35235
Local Institution - 010-855-C
Birmingham, Alabama, 35243
Local Institution - 010-855
Birmingham, Alabama, 35243
Local Institution - 010-922-A
Bonita Springs, Florida, 34135
Local Institution - 010-997
Boston, Massachusetts, 02215
Local Institution - 010-872-A
Boulder, Colorado, 80303
Local Institution - 010-976-C
Bountiful, Utah, 84010
Local Institution - 010-922-D
Bradenton, Florida, 34211
Local Institution - 010-531A
Brownstown, Michigan, 48183
Local Institution - 010-922-E
Cape Coral, Florida, 33909
Local Institution - 010-872-E
Centennial, Colorado, 80112
Local Institution - 010-921
Chattanooga, Tennessee, 37404
Local Institution - 010-979C
Chula Vista, California, 91911
Local Institution - 010-893
Cincinnati, Ohio, 45211
Local Institution - 010-585-B
Clinton, North Carolina, 28328
Local Institution - 010-872-C
Colorado Springs, Colorado, 80907
Local Institution - 010-918 - A
Commack, New York, 11725
Local Institution - 010-572
Dallas, Texas, 75216
Local Institution - 010-879
Dallas, Texas, 75246
Local Institution - 010-531C
Dearborn, Michigan, 48126
Local Institution - 010-872
Denver, Colorado, 80218
Local Institution - 010-872-B
Denver, Colorado, 80220
Local Institution - 010-531
Detroit, Michigan, 48202
Local Institution - 010-975
East Brunswick, New Jersey, 08816
Local Institution - 010-576
Everett, Washington, 98201
Local Institution - 010-919
Fairfax, Virginia, 22031-4630
Local Institution - 010-992
Florham Park, New Jersey, 07932
Local Institution - 010-922
Fort Myers, Florida, 33901
Local Institution - 010-922-B
Fort Myers, Florida, 33905
Local Institution - 010-922-C
Fort Myers, Florida, 33908
Local Institution - 010-597
Fredericksburg, Virginia, 24408
Local Institution - 010-980
Fresno, California, 93701
Local Institution - 010-851
Fullerton, California, 92835
Local Institution - 010-533 B
Gig Harbor, Washington, 98335
Local Institution - 010-996
Gilbert, Arizona, 85234
Local Institution - 010-585
Goldsboro, North Carolina, 27534
Local Institution - 010-566
Goodyear, Arizona, 85338
Local Institution - 010-981
Greenville, South Carolina, 29607
Local Institution - 010-918 - F
Harrison, New York, 10604
Local Institution - 010-860 - A
Henderson, Nevada, 89052
Local Institution - 010-860-F
Henderson, Nevada, 89052
Local Institution - 010-860-B
Henderson, Nevada, 89074
Local Institution - 010-984-B
Holiday, Florida, 34691
Local Institution - 010-577-B
Houston, Texas, 77008
Local Institution - 010-577-A
Houston, Texas, 77024
Local Institution - 010-577
Houston, Texas, 77030
Local Institution - 010-848
Houston, Texas, 77030
Local Institution - 010-977
Houston, Texas, 77090
Local Institution - 010-569-A
Indianapolis, Indiana, 46237-8601
Local Institution - 010-569
Indianapolis, Indiana, 46237-8601
Local Institution - 010-991
Iowa City, Iowa, 52242
Local Institution - 010-999
Irving, Texas, 75063
Local Institution - 010-829
Jacksonville, Florida, 32224
Local Institution - 010-585-A
Jacksonville, North Carolina, 28546
Local Institution - 010-979A
La Mesa, California, 91942
Local Institution - 010-872-J
Lakewood, Colorado, 80228
Local Institution - 010-923-A
Largo, Florida, 33770
Local Institution - 010-923-B
Largo, Florida, 33770
Local Institution - 010-923-C
Largo, Florida, 33770
Local Institution - 010-923-D
Largo, Florida, 33770
Local Institution - 010-923-E
Largo, Florida, 33770
Local Institution - 010-923-F
Largo, Florida, 33770
Local Institution - 010-923-G
Largo, Florida, 33770
Local Institution - 010-923-H
Largo, Florida, 33770
Local Institution - 010-923-I
Largo, Florida, 33770
Local Institution - 010-923-J
Largo, Florida, 33770
Local Institution - 010-923-K
Largo, Florida, 33770
Local Institution - 010-923-L
Largo, Florida, 33770
Local Institution - 010-923-M
Largo, Florida, 33770
Local Institution - 010-923-N
Largo, Florida, 33770
Local Institution - 010-923-O
Largo, Florida, 33770
Local Institution - 010-923-P
Largo, Florida, 33770
Local Institution - 010-860-D
Las Vegas, Nevada, 89128
Local Institution - 010-860-C
Las Vegas, Nevada, 89144
Local Institution - 010-860-E
Las Vegas, Nevada, 89148
Local Institution - 010-860
Las Vegas, Nevada, 89169
Local Institution - 010-976-D
Layton, Utah, 84041
Local Institution - 010-564
Lincoln, Nebraska, 68510
Local Institution - 010-872-F
Littleton, Colorado, 80218
Local Institution - 010-872-G
Longmont, Colorado, 80501
Local Institution - 010-878-B
Longview, Texas, 75601
Local Institution - 010-958A
Los Angeles, California, 90033
Local Institution - 010-958
Los Angeles, California, 90033
Local Institution - 010-551
Los Angeles, California, 90048
Local Institution - 010-990
Miami, Florida, 33136
Local Institution - 010-918 - D
Middletown, New Jersey, 07748
Local Institution - 010-947
Milwaukee, Wisconsin, 53226
Local Institution - 010-875
Minneapolis, Minnesota, 55404
Local Institution - 010-918 - C
Montvale, New Jersey, 07645
Local Institution - 010-575
Morgantown, West Virginia, 26506-9300
Local Institution - 010-976-A
Murray, Utah, 84157
Local Institution - 010-963
Naperville, Illinois, 60540
Local Institution - 010-922-F
Naples, Florida, 34102
Local Institution - 010-922-G
Naples, Florida, 34102
Local Institution - 010-801
Nashville, Tennessee, 37203
Local Institution - 010-957
New Brunswick, New Jersey, 08903-2681
Local Institution - 010-813
New York, New York, 10016
Local Institution - 010-535 - G
New York, New York, 10028
Local Institution - 010-998
New York, New York, 10029
Local Institution - 010-918
New York, New York, 10065
Local Institution - 010-986
Newnan, Georgia, 30265
Local Institution - 010-847
Newport Beach, California, 92663
Local Institution - 010-949
Norwich, Connecticut, 06360
Local Institution - 010-531B
Novi, Michigan, 48377
Local Institution - 010-538
Ocala, Florida, 34474
Local Institution - 010-976-H
Ogden, Utah, 84405
Local Institution - 010-532
Oklahoma City, Oklahoma, 73104
Local Institution - 010-549
Oklahoma City, Oklahoma, 73120
Local Institution - 010-590
Omaha, Nebraska, 68130
Local Institution - 010-896
Orlando, Florida, 32804
Local Institution - 010-988
Orlando, Florida, 32806
Local Institution - 010-535 - C
Patchogue, New York, 11772
Local Institution - 010-989
Phoenix, Arizona, 85054
Local Institution - 010-596
Pittsburgh, Pennsylvania, 15212
Local Institution - 010-922-H
Port Charlotte, Florida, 33980
Local Institution - 010-535 - A
Port Jefferson, New York, 11776
Local Institution - 010-535 - B
Port Jefferson Station, New York, 11776
Local Institution - 010-976-G
Provo, Utah, 84604
Local Institution - 010-872-I
Pueblo, Colorado, 81008
Local Institution - 010-533 C
Puyallup, Washington, 98372
Local Institution - 010-563
Redlands, California, 92373
Local Institution - 010-539
Richmond, Virginia, 23229
Local Institution - 010-536
Richmond, Virginia, 23298
Local Institution - 010-535 - F
Riverhead, New York, 11901
Local Institution - 010-830
Rochester, Minnesota, 55905
Local Institution - 010-838
Saint Louis Park, Minnesota, 55416
Local Institution - 010-838A
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838B
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838C
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838D
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838E
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838F
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838G
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838H
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838I
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838J
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838K
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838L
Saint Louis Park, Minnesota, 55426
Local Institution - 010-838M
Saint Louis Park, Minnesota, 55426
Local Institution - 010-976-B
Salt Lake City, Utah, 84102
Local Institution - 010-976
Salt Lake City, Utah, 84106
Local Institution - 010-862
San Antonio, Texas, 78240
Local Institution - 010-979B
San Diego, California, 92123
Local Institution - 010-979D
San Diego, California, 92123
Local Institution - 010-979
San Diego, California, 92123
Local Institution - 010-982
San Francisco, California, 94115
Local Institution - 010-561
Santa Monica, California, 90404
Local Institution - 010-824
Seattle, Washington, 98109--1023
Local Institution - 010-535
Shirley, New York, 11967
Local Institution - 010-978
Springdale, Arkansas, 72762
Local Institution - 010-541
Springfield, Missouri, 65804
Local Institution - 010-923
St. Petersburg, Florida, 33705
Local Institution - 010-984
St. Petersburg, Florida, 33709-2236
Local Institution - 010-571
Sylmar, California, 91342
Local Institution - 010-533
Tacoma, Washington, 98405
Local Institution - 010-924
Tallahassee, Florida, 32308
Local Institution - 010-964
Temple, Texas, 76508
Local Institution - 010-535 - E
The Bronx, New York, 10469
Local Institution - 010-872-D
Thornton, Colorado, 80260
Local Institution - 010-574
Torrance, California, 90505
Local Institution - 010-984-A
Trinity, Florida, 34655
Local Institution - 010-584
Tulsa, Oklahoma, 74146
Local Institution - 010-878
Tyler, Texas, 75702
Local Institution - 010-918 - E
Uniondale, New York, 11553
Local Institution - 010-885
Vancouver, Washington, 98684
Local Institution - 010-976-E
West Jordan, Utah, 84088
Local Institution - 010-926
West Palm Beach, Florida, 33401
Local Institution - 010-537
Weston, Florida, 33331
Local Institution - 010-570
Whittier, California, 90602
Local Institution - 010-994
Zion, Illinois, 60099
China33 sites
Local Institution - 010-717
Beijing, Beijing Municipality, 100021
Local Institution - 010-712
Bengbu, Anhui, 233004
Local Institution - 010-030
Changchun, Jilin, 130012
Local Institution - 010-718
Changchun, Jilin, 130021
Local Institution - 010-035
Changsha, Hunan, 410008
Local Institution - 010-710
Chengdu, Sichuan, 610044
Local Institution - 010-029
Fuzhou, Fujian, 350014
Local Institution - 010-031
Guangzhou, Guangdong, 510655
Local Institution - 010-707
Hangzhou, Zhejiang, 310009
Local Institution - 010-034
Hangzhou, Zhejiang, 310022
Local Institution - 010-032
Hangzhou, 310016
Local Institution - 010-026
Hefei, Anhui, 230001
Local Institution - 010-022
Hefei, Anhui, 230022
Local Institution - 010-711
Hefei, Anhui, 230031
Local Institution - 010-033
Hongkou Qu, 200080
Local Institution - 010-714
Jiangyin, Jiangsu, 214400
Local Institution - 010-036
Jinan, Shandong, 250117
Local Institution - 010-706
Nanchang, Jiangxi, 330006
Local Institution - 010-704
Nanjing, Jiangsu, 210029
Local Institution - 010-715
Nanning, Guangxi, 530021
Local Institution - 010-716
Neijiang, Sichuan, 641199
Local Institution - 010-038
Shanghai, Shanghai Municipality, 200080
Local Institution - 010-020
Shanghai, Shanghai Municipality, 200120
Local Institution - 010-708
Shanghai, Shanghai Municipality, 200240
Local Institution - 010-025
Shanghai Shi, Shanghai Municipality, 200025
Local Institution - 010-024
Shanghaishi, Shanghai Municipality, 200032
Local Institution - 010-709
Shenyang, Liaoning, 110001
Local Institution - 010-705
Shenyang, Liaoning, 110042
Local Institution - 010-713
Shenzhen, Guangdong, 518036
Local Institution - 010-027
Tianjin, Tianjin Municipality, 300060
Local Institution - 010-703
Wuhan, Hubei, 430030
Local Institution - 010-701
Wuhan, Hubei, 430079
Local Institution - 010-021
Zhengzhou, Henan, 450008
France18 sites
Local Institution - 010-668
Avignon, 84918
Local Institution - 010-208
Besançon, 25000
Local Institution - 010-669
Bordeaux, 33000
Local Institution - 010-194
Brest, 29200
Local Institution - 010-209-A
Chambray-lès-Tours, Centre-Val de Loire, 37170
Local Institution - 010-192
Dijon, 21079
Local Institution - 010-662
Lille, 59037
Local Institution - 010-205
Lyon, 69008
Local Institution - 010-682
Marseille, 13005
Local Institution - 010-207
Paris, 75010
Local Institution - 010-203
Paris, 75012
Local Institution - 010-204
Paris, 75013
Local Institution - 010-661
Paris, 75015
Local Institution - 010-660
Pessac, 33720
Local Institution - 010-667
Suresnes, 92150
Local Institution - 010-680
Toulouse, 31059
Local Institution - 010-209
Tours, 37044
Local Institution - 010-202
Villejuif, 94805
South Korea15 sites
Local Institution - 010-116
Anyang-si, 14068
Local Institution - 010-111
Busan, 48108
Local Institution - 010-119
Busan, 602-812
Local Institution - 010-525
Daejeon, 35015
Local Institution - 010-117
Goyang-si, 10408
Local Institution - 010-100
Hwasun-gun, 58128
Local Institution - 010-520
Seongnam-si, 13496
Local Institution - 010-105
Seoul, 02841
Local Institution - 010-108
Seoul, 03080
Local Institution - 010-118
Seoul, 03722
Local Institution - 010-104
Seoul, 05505
Local Institution - 010-114
Seoul, 06351
Local Institution - 010-109
Seoul, 06591
Local Institution - 010-115
Suwon, 16247
Local Institution - 010-524
Yangsan, 50612
Spain15 sites
Local Institution - 010-613
A Coruña, 15006
Local Institution - 010-610
Badalona, 08916
Local Institution - 010-612
Barcelona, 08035
Local Institution - 010-600
Barcelona, 08036
Local Institution - 010-621
Córdoba, 14004
Local Institution - 010-620
LHospitalet de Llobregat, 08908
Local Institution - 010-619
Madrid, 28007
Local Institution - 010-601
Madrid, 28040
Local Institution - 010-617
Madrid, 28041
Local Institution - 010-624
Madrid, 28046
Local Institution - 010-623
Pamplona, 31008
Local Institution - 010-622
Sabadell, 08208
Local Institution - 010-604
Santander, 39008
Local Institution - 010-618
Valencia, 46010
Local Institution - 010-625
Valencia, 46014
Italy14 sites
Local Institution - 010-292
Avellino, 83100
Local Institution - 010-290
Biella, 13875
Local Institution - 010-299
Cagliari, 9042
Local Institution - 010-286
Candiolo, 10060
Local Institution - 010-287
Lido di Camaiore, 55041
Local Institution - 010-270
Meldola, 47014
Local Institution - 010-278
Milan, 20141
Local Institution - 010-293
Milan, 20162
Local Institution - 010-271
Naples, 80131
Local Institution - 010-297
Padova, 35128
Local Institution - 010-294
Pisa, 56126
Local Institution - 010-291
Reggio Emilia, 42100
Local Institution - 010-295
Roma, 00144
Local Institution - 010-289
Torino, 10128
Germany12 sites
Local Institution - 010-675
Amberg, 92224
Local Institution - 010-657
Berlin, 10117
Local Institution - 010-655
Bochum, 44791
Local Institution - 010-227
Dresden, 01307
Local Institution - 010-229
Frankfurt am Main, 60488
Local Institution - 010-656
Hamburg, D-20249
Local Institution - 010-658
Herne, 44625
Local Institution - 010-228
Mönchengladbach, 41063
Local Institution - 010-650
München, 81377
Local Institution - 010-226
München, 81737
Local Institution - 010-652
Reutlingen, 72764
Local Institution - 010-676
Ulm, 89081
United Kingdom12 sites
Local Institution - 010-412
Aberdeen, AB25 2ZN
Local Institution - 010-410
Birmingham, B15 2WB
Local Institution - 010-413
Cambridge, CB2 0QQ
Local Institution - 010-411
Dorset, BH7 7DW
Local Institution - 010-400
Glasgow, G12 0XH
Local Institution - 010-403
Kent, ME16 9QQ
Local Institution - 010-414
Leeds, LS9 7TF
Local Institution - 010-402
London, NW1 2BU
Local Institution - 010-405
London, SW3 6JJ
Local Institution - 010-406
London, SW3 6JJ
Local Institution - 010-407
Manchester, M20 4BX
Local Institution - 010-404
Middlesex, HA6 2RN
Brazil10 sites
Local Institution - 010-450
Blumenau, Santa Catarina, 89010-340
Local Institution - 010-442
Curitiba, 80040-170
Local Institution - 010-446
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 010-449
Liberdade, 01509-010
Local Institution - 010-443
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution - 010-444
Santo André, 09060-650
Local Institution - 010-440
São José do Rio Preto, 15090-000
Local Institution - 010-441
São Paulo, 01246-000
Local Institution - 010-445
São Paulo, 01323-030
Local Institution - 010-447
São Paulo, 04543-000
Romania8 sites
Local Institution - 010-347
Baia Mare, 430031
Local Institution - 010-349
Brasov, 500152
Local Institution - 010-512
Bucharest, 022328
Local Institution - 010-344
Cluj-Napoca, 400015
Local Institution - 010-340
Cluj-Napoca, 400641
Local Institution - 010-343
Craiova, 200746
Local Institution - 010-511
Ovidiu, 905900
Local Institution - 010-510
Timișoara, 300239
Mexico7 sites
Local Institution - 010-471
Colonia Centro Orizaba, Veracruz, 94300
Local Institution - 010-476
Cuernavaca, Morelos, 62290
Local Institution - 010-472
Guadalajara, Jalisco, 44280
Local Institution - 010-477
Guadalajara, Jalisco, 44670
Local Institution - 010-473
Mexico City, Mexico City, 14080
Local Institution - 010-475
San Juan del Río, Querétaro, 76800
Local Institution - 010-474
Tuxtla Gutiérrez, Chiapas, 29038
Taiwan7 sites
Local Institution - 010-129
Changhua, 500
Local Institution - 010-121
Kaohsiung City, 807
Local Institution - 010-124
Taichung, 40705
Local Institution - 010-122
Tainan, 704
Local Institution - 010-123
Tainan, 73657
Local Institution - 010-120
Taipei, 10002
Local Institution - 010-125
Taoyuan, 333
Argentina6 sites
Local Institution - 010-434
Buenos Aires, C1426ANZ
Local Institution - 010-431
Buenos Aires, CI264 AAA
Local Institution - 010-432
CABA, 1061
Local Institution - 010-430
La Rioja, F5300COE
Local Institution - 010-448
Porto Alegre, 91350-200
Local Institution - 010-433
Viedma, R8500ACE
Australia6 sites
Local Institution - 010-005
Bedford Park, 5042
Local Institution - 010-004
Clayton, 3168
Local Institution - 010-006
Garran, 2065
Local Institution - 010-015
Heidelberg, 3084
Local Institution - 010-012
Melbourne, 3004
Local Institution - 010-002
Waratah, 2298
Greece6 sites
Local Institution - 010-501
Athens, 11528
Local Institution - 010-232
Cholargós, 155 62
Local Institution - 010-238
Heraklion, 71110
Local Institution - 010-235
Larissa, 41110
Local Institution - 010-231
Thessaloniki, 54645
Local Institution - 010-230
Thessaloniki, 57001
Malaysia6 sites
Local Institution - 010-070
Johor Bahru, Johor, 81100
Local Institution - 010-077
Kota Kinabalu, Sabah, 88996
Local Institution - 010-073
Kuala Lumpur, 50586
Local Institution - 010-074
Kuala Lumpur, 50603
Local Institution - 010-071
Petaling Jaya, Selangor, 46050
Local Institution - 010-072
Putrajaya, 62250
Ireland5 sites
Local Institution - 010-250
Dublin, 4
Local Institution - 010-252
Dublin, 9
Local Institution - 010-253
Dublin, D07 R2WY
Local Institution - 010-254
Dublin, D07 WKW8
Local Institution - 010-251
Dublin, D24 NR0A
Portugal5 sites
Local Institution - 010-332
Braga, 4710-243
Local Institution - 010-337
Lisbon, 1400-038
Local Institution - 010-640
Lisbon, 1649-035
Local Institution - 010-331
Porto, 4099-001
Local Institution - 010-339
Porto, 4200-072
Singapore5 sites
Local Institution - 010-090
Singapore, 119074
Local Institution - 010-093
Singapore, 168583
Local Institution - 010-095
Singapore, 188770
Local Institution - 010-092
Singapore, 217562
Local Institution - 010-091
Singapore, 258499
Thailand5 sites
Local Institution - 010-132
Bang Phlat, 10700
Local Institution - 010-134
Bangkok, 10400
Local Institution - 010-131
Chiang Mai, 50200
Local Institution - 010-130
Hat Yai, 90110
Local Institution - 010-133
Khlong Toey, 10110
Belgium4 sites
Local Institution - 010-154
Brussels, 1090
Local Institution - 010-157
Edegem, 2650
Local Institution - 010-156
Ghent, 9000
Local Institution - 010-150
Yvoir, B-5530
Canada4 sites
Local Institution - 010-487
Montreal, Quebec, H1T 2M4
Local Institution - 010-481
Ottawa, Ontario, K1H 8L6
Local Institution - 010-483
Toronto, Ontario, M5B 1W8
Local Institution - 010-482
Toronto, Ontario, M5G 2M9
Colombia4 sites
Local Institution - 010-460
Barranquilla, 080020
Local Institution - 010-462
Bogotá, 0
Local Institution - 010-465
Floridablanca, 0
Local Institution - 010-463
Medellín, 050034
Czechia4 sites
Local Institution - 010-165
Brno, 656 53
Local Institution - 010-160
Brno, 656 91
Local Institution - 010-162
Olomouc, 779 00
Local Institution - 010-161
Prague, 150 06
Netherlands4 sites
Local Institution - 010-632
Amsterdam, 1066 CX
Local Institution - 010-306
Amsterdam, 1081 HV
Local Institution - 010-630
Nijmegen, 6525 GA
Local Institution - 010-307
Utrecht, 3543 AZ
Poland4 sites
Local Institution - 010-328
Gdansk, 80-219
Local Institution - 010-327
Otwock, 05-400
Local Institution - 010-322
Warsaw, 02-034
Local Institution - 010-787
Warsaw, 02-507
Austria3 sites
Local Institution - 010-145
Innsbruck, 6020
Local Institution - 010-144
Vienna, 1090
Local Institution - 010-143
Wiener Neustadt, 2700
Denmark3 sites
Local Institution - 010-171
Copenhagen, 2100
Local Institution - 010-172
Odense, 5000
Local Institution - 010-170
Vejle, 7100
Finland3 sites
Local Institution - 010-180
Helsinki, FI-00029
Local Institution - 010-182
Tampere, 33520
Local Institution - 010-181
Turku, 20521
Puerto Rico3 sites
Local Institution - 010-902
San Juan, 00919
Local Institution - 010-903
San Juan, 00927
Local Institution - 010-900
San Juan, 00935
Hong Kong2 sites
Local Institution - 010-048
Central, 0
Local Institution - 010-046
Hong Kong, 0
About this study
Official title: 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.
- Being tested
- MRTX849, Cetuximab, mFOLFOX6 Regimen, FOLFIRI Regimen
- Keywords
- Colorectal Cancer, Colorectal Cancer Trial, Colorectal Carcinoma, Rectal Cancer, Colon Cancer, KRAS, KRAS G12C, RAS, Colorectal Adenocarcinoma
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX849Drug
28 Day Cycle
CetuximabBiological
Also called Erbitux
28 Day Cycle
mFOLFOX6 RegimenDrug
- Fluorouracil
- Oxaliplatin
- Folinic acid
FOLFIRI RegimenDrug
- Fluorouracil
- Irinotecan
- Folinic acid
| Study group | Role | What they receive |
|---|---|---|
| MRTX849 + Cetuximab | Experimental | Not described Receives: Drug: MRTX849; Biological: Cetuximab |
| mFOLFOX6 or FOLFIRI | Active comparator | Not described Receives: Drug: mFOLFOX6 Regimen; Drug: FOLFIRI Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as time from date of randomization to date of death due to any cause.
Measured: 30 months
Progression-free Survival (PFS)
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Measured: 30 months
Secondary outcomes (5)
Adverse Events
Defined as number of patients with treatment emergent AEs.
Measured: 30 months
Objective Response Rate (ORR)
Defined as the percent of patients documented to have a confirmed CR or PR.
Measured: 30 months
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.
Measured: 30 months
Patient Reported Outcomes (PROs)
To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).
Measured: 30 months
Quality of Life Assessment
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start24 Jun 2021
- Primary completion16 Jan 2026
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793958
- Sponsor's protocol ID
- CA239-0006
- Other IDs
- KRYSTAL-10, CA239-0006, 849-010
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Publications
Deming DA. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer. J Natl Compr Canc Netw. 2025 Jan 3;23(1):e247067. doi: 10.6004/jnccn.2024.7067.
PubMed 39752885
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04793958
- Acronym / sponsor ID
- CA239-0006
- Keywords
- Colorectal Cancer, Colorectal Cancer Trial, Colorectal Carcinoma, Rectal Cancer, Colon Cancer, KRAS, KRAS G12C, RAS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRTX849 + Cetuximab | Experimental | Drug: MRTX849, Biological: Cetuximab |
| mFOLFOX6 or FOLFIRI | Active comparator | Drug: mFOLFOX6 Regimen, Drug: FOLFIRI Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRTX84928 Day Cycle | Drug | MRTX849 + Cetuximab |
| CetuximabAlso: Erbitux28 Day Cycle | Biological | MRTX849 + Cetuximab |
| mFOLFOX6 Regimen* Fluorouracil * Oxaliplatin * Folinic acid | Drug | mFOLFOX6 or FOLFIRI |
| FOLFIRI Regimen* Fluorouracil * Irinotecan * Folinic acid | Drug | mFOLFOX6 or FOLFIRI |
Primary outcome
Overall Survival (OS)
Time frame: 30 months
Defined as time from date of randomization to date of death due to any cause.
Progression-free Survival (PFS)
Time frame: 30 months
Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
5 secondary outcomes
Adverse Events
Time frame: 30 months
Objective Response Rate (ORR)
Time frame: 30 months
Duration of Response (DOR)
Time frame: 30 months
Patient Reported Outcomes (PROs)
Time frame: 30 months
Quality of Life Assessment
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 39752885Deming DA. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer. J Natl Compr Canc Netw. 2025 Jan 3;23(1):e247067. doi: 10.6004/jnccn.2024.7067.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
419 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRTX849, Cetuximab and mFOLFOX6 Regimen in people with Advanced Colorectal Cancer and Metastatic Colorectal Cancer, run by Mirati Therapeutics Inc. at 419 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 419 sites in United States, China, France, South Korea, Spain and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04793958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.