A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

June 11, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.

Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.

The goals of this study are to learn:

  • About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments
  • If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will have 2 parts.

Study Type

Interventional

Enrollment (Estimated)

477

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Córdoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Universitario de Córdoba ( Site 0108)
        • Contact:
          • Study Coordinator
          • Phone Number: +543514688846
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491155960279
      • Mar del Plata, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491166936669
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000CEJ
        • Recruiting
        • Fundacion Estudios Clinicos ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +5493413168137
      • Rosario, Santa Fe Province, Argentina, S2000CUB
        • Recruiting
        • Sanatorio Parque ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: +5493464586234
  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Wollongong Hospital ( Site 0453)
        • Contact:
          • Study Coordinator
          • Phone Number: +61242225000
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital ( Site 0451)
        • Contact:
          • Study Coordinator
          • Phone Number: +61752020000
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health ( Site 0454)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 03 8572-2941
      • St Albans, Victoria, Australia, 3021
        • Recruiting
        • Western Health-Sunshine & Footscray Hospitals ( Site 0450)
        • Contact:
          • Study Coordinator
          • Phone Number: +61383959167
  • Brazil
      • São Paulo, Brazil, 01209-000
        • Recruiting
        • Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 11 3225-0155
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
        • Contact:
          • Study Coordinator
          • Phone Number: +551134744222
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Recruiting
        • Hospital de Câncer de Recife ( Site 0158)
        • Contact:
          • Study Coordinator
          • Phone Number: +558132178084
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Recruiting
        • Hospital de Caridade de Ijuí ( Site 0150)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 55 981580022
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
        • Recruiting
        • Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: +555433164000
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 0156)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551993590437
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88020-210
        • Recruiting
        • CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)
        • Contact:
          • Study Coordinator
          • Phone Number: +554833804828
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)
        • Contact:
          • Study Coordinator
          • Phone Number: +551733216600
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 17 3201-5054
      • São José dos Campos, São Paulo, Brazil, 12242-660
        • Recruiting
        • COE Ensino e Pesquisa ( Site 0151)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511960903468
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • Cancercare Manitoba ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 204-787-4156
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • Moncton Hospital - Horizon Health Network ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068575756
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-4559
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)
        • Contact:
          • Study Coordinator
          • Phone Number: 41854112342707
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Département clinique de médecine de laboratoire du CHUM ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-340-8222
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4810148
        • Recruiting
        • CIDO SpA ( Site 0212)
        • Contact:
          • Study Coordinator
          • Phone Number: +56452657374
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Recruiting
        • Clínica Puerto Montt ( Site 0206)
        • Contact:
          • Study Coordinator
          • Phone Number: +56652484800
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia ( Site 0204)
        • Contact:
          • Study Coordinator
          • Phone Number: 56958537020
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • Fundacion Arturo Lopez Perez ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 0211)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991290140
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión ( Site 0207)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991612199
      • Vitacura, Region M. de Santiago, Chile, 7650018
        • Recruiting
        • Clínica RedSalud Vitacura ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +56223954046
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: +56323320850
  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincial Cancer Hospital ( Site 0803)
        • Contact:
          • Study Coordinator
          • Phone Number: 0551-65327666
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Affiliated Hospital of Anhui Medical University ( Site 0813)
        • Contact:
          • Study Coordinator
          • Phone Number: 0551-63869536
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital ( Site 0824)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613910113193
      • Beijing, Beijing Municipality, China, 102627
        • Recruiting
        • Peking University First Hospital(Daxing Area) ( Site 0838)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-56957544
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 0808)
        • Contact:
          • Study Coordinator
          • Phone Number: 13983841209
      • Wanzhou, Chongqing Municipality, China, 404199
        • Recruiting
        • Chongqing University Three Gorges Hospital ( Site 0837)
        • Contact:
          • Study Coordinator
          • Phone Number: 023-58103019
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital ( Site 0807)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13509339525
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13575559341
      • Xiamen, Fujian, China, 361004
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: +8605922292201
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02087343565
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital ( Site 0812)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 02062786845
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-38254000
      • Shenzhen, Guangdong, China, 518053
        • Recruiting
        • The University of Hong Kong - Shenzhen Hospital ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +86075586913333
    • Guangxi
      • Nanning, Guangxi, China, 530200
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 07715323175
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital ( Site 0822)
        • Contact:
          • Study Coordinator
          • Phone Number: 037165587161
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83663940
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital ( Site 0814)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-87670500
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University ( Site 0834)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-88638888
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0815)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762130
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)
        • Contact:
          • Study Coordinator
          • Phone Number: 025-83106666
    • Jiangxi
      • Nanchang, Jiangxi, China, 330200
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 0826)
        • Contact:
          • Study Coordinator
          • Phone Number: 0791-88692748
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: 029-85324783
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital ( Site 0817)
        • Contact:
          • Study Coordinator
          • Phone Number: 0531-55739999
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 0816)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-64175590
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital of Fudan University ( Site 0832)
        • Contact:
          • Study Coordinator
          • Phone Number: 02164041990
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: +8615121110481
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Affiliated Hospital of Shanxi Medical University ( Site 0843)
        • Contact:
          • Study Coordinator
          • Phone Number: 0351-4639931
    • Sichuan
      • Chengdu, Sichuan, China, 610213
        • Recruiting
        • Sichuan Cancer hospital. ( Site 0831)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85420509
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85422707
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University ( Site 0845)
        • Contact:
          • Study Coordinator
          • Phone Number: 087165324888
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310017
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-87783777
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital ( Site 0821)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-88122222
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)
        • Contact:
          • Study Coordinator
          • Phone Number: +86057755579591
  • Colombia
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110231
        • Recruiting
        • Hospital Universitario San Ignacio ( Site 0254)
        • Contact:
          • Study Coordinator
          • Phone Number: +573152931879
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Recruiting
        • IMAT S.A.S ( Site 0252)
        • Contact:
          • Study Coordinator
          • Phone Number: +576047862333
    • Risaralda Department
      • Pereira, Risaralda Department, Colombia, 660001
        • Recruiting
        • Oncologos Del Occidente ( Site 0255)
        • Contact:
          • Study Coordinator
          • Phone Number: +57 3187715522
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampere University Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +358503375000
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +358504272703
  • France
      • Paris, France, 75571
        • Recruiting
        • Hôpital Saint Antoine ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: +33149281839
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492036021
    • Calvados
      • Caen, Calvados, France, 14000
        • Recruiting
        • Centre François Baclesse ( Site 1061)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231455050
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU Rangueil ( Site 1063)
        • Contact:
          • Study Coordinator
          • Phone Number: +33561322142
    • Limousin
      • Limoges, Limousin, France, 87042
        • Recruiting
        • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)
        • Contact:
          • Study Coordinator
          • Phone Number: +33555056396
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54511
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: +33772081634
    • Marne
      • Reims, Marne, France, 51100
        • Recruiting
        • Institut Jean Godinot ( Site 1054)
        • Contact:
          • Study Coordinator
          • Phone Number: +33326504246
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49055
        • Recruiting
        • Institut de Cancérologie de l'Ouest ( Site 1062)
        • Contact:
          • Study Coordinator
          • Phone Number: +33241352700
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76031
        • Recruiting
        • CHU Charles Nicolle ( Site 1066)
        • Contact:
          • Study Coordinator
          • Phone Number: +33232888148
    • Vaucluse
      • Avignon, Vaucluse, France, 84918
        • Recruiting
        • Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: +33490276161
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou ( Site 1050)
        • Contact:
          • Study Coordinator
          • Phone Number: +33156092000
  • Germany
      • Hamburg, Germany, 22087
        • Recruiting
        • Katholisches Marienkrankenhaus gGmbH ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: 00494025460
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049401818810
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2255 3838
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital. ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: + 852 3505 2211
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7624
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +3672536480
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1253)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247776234
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 1252)
        • Contact:
          • Study Coordinator
          • Phone Number: 02-6777111
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1251)
        • Contact:
          • Study Coordinator
          • Phone Number: 03-9377589
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1254)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235303030
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 1255)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236974444
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele. ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: +39.0226435138
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390815666760
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: 390498215910
      • Ravenna, Italy, 48100
        • Recruiting
        • Azienda USL della Romagna ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390544285247
      • Verona, Italy, 37134
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 00393200117982
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Recruiting
        • AOU Cagliari ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 07051096037
    • Lombardy
      • Milan, Lombardy, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390264442291
  • Japan
      • Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center ( Site 0858)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-43-264-5431
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 0862)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-642-5774
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0852)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 0851)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 006-8555
        • Recruiting
        • Teine Keijinkai Hospital ( Site 0864)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-681-8111
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital ( Site 0861)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-87-891-2345
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 0853)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital ( Site 0854)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-366-0221
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 0860)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Recruiting
        • Saitama Prefectural Cancer Center ( Site 0857)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-48-722-1111
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Recruiting
        • Shizuoka Cancer Center ( Site 0856)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-55-989-5222
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 0859)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Chūō, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital ( Site 0850)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3542-2511
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 0863)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
  • Malaysia
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Recruiting
        • Hospital Pulau Pinang ( Site 0550)
        • Contact:
          • Study Coordinator
          • Phone Number: +6042225333
    • Putrajaya
      • Putrajaya, Putrajaya, Malaysia, 62250
        • Recruiting
        • National Cancer Institute ( Site 0552)
        • Contact:
          • Study Coordinator
          • Phone Number: +60388925555
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital ( Site 0551)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276666
  • Mexico
      • Aguascalientes, Mexico, 20124
        • Recruiting
        • Centro de Investigación Oncológica Galerías SC ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: +525527280926
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +529516035559
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 1354)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 24 3610353
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 76 5951006
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, locatie VUmc ( Site 1351)
        • Contact:
          • Study Coordinator
          • Phone Number: +31204444321
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-866
        • Recruiting
        • Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)
        • Contact:
          • Study Coordinator
          • Phone Number: +48943488930
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-034
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1451)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225709241
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1452)
        • Contact:
          • Study Coordinator
          • Phone Number: +48322788237
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 1456)
        • Contact:
          • Study Coordinator
          • Phone Number: +48943488930
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute-Medical Oncology ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +4021 275 0500
      • Iași, Romania, 700483
        • Recruiting
        • Institutul Regional de Oncologie ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +40374278811
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Institutul Oncologic Cluj ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +40 264 598 362
      • Cluj-Napoca, Cluj, Romania, 407280
        • Recruiting
        • SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: 021 9368
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Recruiting
        • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)
        • Contact:
          • Study Coordinator
          • Phone Number: +40 731 604 432
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 0650)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-1588-5700
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital ( Site 0704)
        • Contact:
          • Study Coordinator
          • Phone Number: 82226263060
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • Recruiting
        • National Cancer Center ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +82319201737
      • Seongnam-si, Kyonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +8215883369
      • Suwon, Kyonggi-do, South Korea, 16247
        • Recruiting
        • The Catholic University of Korea St. Vincent s Hospital ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-31-881-8893
    • Seoul
      • Gangnam, Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 0708)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234100297
      • Songpa-gu, Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-3010-3204
    • Taegu-Kwangyokshi
      • Buk-Gu, Taegu-Kwangyokshi, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +82532003011
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1553)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 93 489 43 50
      • Madrid, Spain, 28007
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914269325
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos ( Site 1555)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913303000x484833
      • Seville, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 955 013 068
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia - IVO ( Site 1557)
        • Contact:
          • Study Coordinator
          • Phone Number: 34961114000
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 934 97 89 25
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla ( Site 1551)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 942202525
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Insular de Gran Canaria ( Site 1558)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 928441738
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias ( Site 1550)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 985108000x36582
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 0754)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital ( Site 0751)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-2-23123456
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 0752)
        • Contact:
          • Study Coordinator
          • Phone Number: +886228712121
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1652)
        • Contact:
          • Study Coordinator
          • Phone Number: +905334473857
      • Ankara, Turkey (Türkiye), 06560
        • Recruiting
        • Gazi Universitesi ( Site 1651)
        • Contact:
          • Study Coordinator
          • Phone Number: +900552 405 94 79
      • Diyarbakır, Turkey (Türkiye), 21200
        • Recruiting
        • Dicle Üniversitesi ( Site 1654)
        • Contact:
          • Study Coordinator
          • Phone Number: +9005531193420
      • Istanbul, Turkey (Türkiye), 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa ( Site 1656)
        • Contact:
          • Study Coordinator
          • Phone Number: 90 537 998 3832
      • Izmir, Turkey (Türkiye), 35080
        • Recruiting
        • Ege Universitesi Hastanesi ( Site 1653)
        • Contact:
          • Study Coordinator
          • Phone Number: +900538 269 01 34
    • Ankara
      • Sıhhiye, Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri ( Site 1650)
        • Contact:
          • Study Coordinator
          • Phone Number: +90506 099 24 19
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Recruiting
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +380669472333
      • Kyiv, Ukraine, 03126
        • Recruiting
        • SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)
        • Contact:
          • Study Coordinator
          • Phone Number: +380956017249
      • Kyiv, Ukraine, 03151
        • Recruiting
        • LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +380671502987
    • Cherkasy Oblast
      • Cherkasy, Cherkasy Oblast, Ukraine, 18009
        • Recruiting
        • MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +380472319418
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
        • Recruiting
        • RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)
        • Contact:
          • Study Coordinator
          • Phone Number: 0443344770
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
        • Recruiting
        • MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +380966059053
    • Kirovohrad Oblast
      • Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
        • Recruiting
        • CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +380508427973
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79059
        • Recruiting
        • MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: +380977453295
    • Rivne Oblast
      • Rivne, Rivne Oblast, Ukraine, 33017
        • Recruiting
        • MNE "Central City Hospital" ( Site 1711)
        • Contact:
          • Study Coordinator
          • Phone Number: +380508266088
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, +380332773100
        • Recruiting
        • ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)
        • Contact:
          • Study Coordinator
          • Phone Number: 380503782998
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Recruiting
        • Uzhgorod Central City Clinical Hospital ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +380953274431
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 1755)
        • Contact:
          • Study Coordinator
          • Phone Number: +441614468370
    • England
      • Birmingham, England, United Kingdom, B9 5ss
        • Recruiting
        • Heartlands Hospital ( Site 1759)
        • Contact:
          • Study Coordinator
          • Phone Number: +4401214241396
    • London, City of
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals ( Site 1750)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 3456 7890
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, ox3 7le
        • Recruiting
        • Churchill Hospital ( Site 1756)
        • Contact:
          • Study Coordinator
          • Phone Number: +4403003047777
  • United States
    • California
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Los Angeles Hematology Oncology Medical Group ( Site 0084)
        • Contact:
          • Study Coordinator
          • Phone Number: 213-533-9655
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-493-6337
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers (RMCC) ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-925-0700
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists - South ( Site 7002)
        • Contact:
          • Study Coordinator
          • Phone Number: 239-274-9930
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute ( Site 0065)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-841-6780
      • St. Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists - North ( Site 7001)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-216-1143
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists - East ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 561-366-4100
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa ( Site 0074)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-4200
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-218-1758
      • Louisville, Kentucky, United States, 40217
        • Recruiting
        • Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-636-7845
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Greater Baltimore Medical Center ( Site 0068)
        • Contact:
          • Study Coordinator
          • Phone Number: 443-849-3051
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic ( Site 0064)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-288-2495
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-238-6685
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center ( Site 0078)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-559-4000
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 775-982-4000
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
        • Contact:
          • Study Coordinator
          • Phone Number: 551-996-5855
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Recruiting
        • San Juan Oncology Associates, P.C ( Site 2011)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-564-6850
    • New York
      • Schenectady, New York, United States, 12308
        • Recruiting
        • Ellis Hospital ( Site 0098)
        • Contact:
          • Study Coordinator
          • Phone Number: 518-243-4762
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South ( Site 0075)
        • Contact:
          • Study Coordinator
          • Phone Number: 937-438-2400
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW ( Site 8002)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1000
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 0059)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-9685
      • Denison, Texas, United States, 75020
        • Recruiting
        • Texas Oncology - Northeast Texas ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-868-4700
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio ( Site 8004)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-595-5300
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Community Cancer Trials of Utah ( Site 0086)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-689-3909
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia ( Site 0080)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-243-8237
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 703-280-5390
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-616-9025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma
  • Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period
  • Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy
  • Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease
  • Has active infection requiring systemic therapy
  • Has not adequately recovered from major surgery or have ongoing surgical complications
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mFOLFOX6
Participants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.
Drug: Oxaliplatin
Per label
Drug: Leucovorin/levofolinate calcium
Per label
Drug: 5-Fluorouracil
Per label
Drug: Bevacizumab
Per label
Other Names:
  • Avastin
Drug: Bevacizumab biosimilar
Per label
Other Names:
  • MVASI
Experimental: Calderasib + Cetuximab + mFOLFOX6
Participants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met.
Drug: Oxaliplatin
Per label
Drug: Leucovorin/levofolinate calcium
Per label
Drug: 5-Fluorouracil
Per label
Biological: Cetuximab
Per label
Other Names:
  • Erbitux
Drug: Calderasib
Oral tablet
Other Names:
  • MK-1084

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Time Frame: Up to approximately 28 days
A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration.
Up to approximately 28 days
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 44 months
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 44 months
Progression Free Survival (PFS)
Time Frame: Up to approximately 44 months
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Up to approximately 44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 5 years
Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR is defined as a confirmed complete response (CR: the disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to approximately 3 years
Duration of Response (DOR)
Time Frame: Up to approximately 4 years
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 4 years
Part 2: Number of Participants with an Adverse Event (AE)
Time Frame: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 5 years
Part 2: Number of Participants who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Up to approximately 5 years
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented. A higher score indicates a better outcome.
Baseline and up to approximately 5 years
Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score will be presented.
Baseline and up to approximately 5 years
Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be presented.
Baseline and up to approximately 5 years
Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of life questionnaire, including a single-item scale score for appetite loss (QLQ-C30 Item 13). For this item, individual responses to the question "Have you lacked appetite?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 appetite loss (Item 13) scale score will be presented.
Baseline and up to approximately 5 years
Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). For this item, individual responses to the question "Did you have a bloated feeling in your abdomen?" are given on a 4-point scale (1=Not at all; 4=Very much). Scores are transformed to a range from 0-100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-CR29 bloating (Item 37) scale score will be presented.
Baseline and up to approximately 5 years
Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in global health status (GHS) (EORTC QLQ-C30 Item 29) & quality of life (QoL) combined score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.
Baseline and up to approximately 5 years
TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in GHS and QoL combined score, will be presented. A longer TTD indicates a better outcome.
Baseline and up to approximately 5 years
TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline and up to approximately 5 years
TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in appetite loss score (EORTC QLQ-C30 Item 13). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
Baseline and up to approximately 5 years
TTD in EORTC QLQ-CR29 Bloating (Item 37) Score
Time Frame: Baseline and up to approximately 5 years
The EORTC QLQ-CR29 is a health-related quality-of life questionnaire specific for colorectal cancer, including a single-item scale score for bloating (QLQ-CR29 Item 37). TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in bloating score (QLQ-CR29 Item 37). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in appetite loss score, will be presented. A longer TTD indicates a better outcome.
Baseline and up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

March 28, 2029

Study Completion (Estimated)

October 27, 2030

Study Registration Dates

First Submitted

May 21, 2025

First Submitted That Met QC Criteria

May 21, 2025

First Posted (Actual)

May 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1084-012
  • MK-1084-012 (Other Identifier: MSD)
  • KANDLELIT-012 (Other Identifier: MSD)
  • 2024-517232-22-00 (Registry Identifier: EU CT)
  • U1111-1311-8311 (Registry Identifier: UTN)
  • jRCT2031250265 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rectal Adenocarcinoma

Clinical Trials on Oxaliplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe