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A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
477
Start Date
2025-07-16
Completion Date
2030-10-27
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Calderasib
Oral tablet
Oxaliplatin
Per label
Leucovorin/levofolinate calcium
Per label
5-Fluorouracil
Per label
Cetuximab
Per label
Bevacizumab
Per label
Bevacizumab biosimilar
Per label
Locations (143)
Los Angeles Hematology Oncology Medical Group ( Site 0084)
Los Angeles, California, United States
Orlando Health Cancer Institute ( Site 0065)
Orlando, Florida, United States
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
University of Iowa ( Site 0074)
Iowa City, Iowa, United States
University of Kentucky ( Site 0055)
Lexington, Kentucky, United States
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
Louisville, Kentucky, United States
Greater Baltimore Medical Center ( Site 0068)
Baltimore, Maryland, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)
Billings, Montana, United States
University Of Nebraska Medical Center ( Site 0078)
Omaha, Nebraska, United States
Renown Regional Medical Center ( Site 0056)
Reno, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
Hackensack, New Jersey, United States
Miami Valley Hospital South ( Site 0075)
Centerville, Ohio, United States
Community Cancer Trials of Utah ( Site 0086)
Ogden, Utah, United States
University of Virginia ( Site 0080)
Charlottesville, Virginia, United States
Hospital Italiano de Buenos Aires ( Site 0102)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0101)
Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos ( Site 0105)
Rosario, Santa Fe Province, Argentina
Hospital Privado Universitario de Córdoba ( Site 0108)
Córdoba, Argentina
Sunshine Coast University Hospital ( Site 0451)
Birtinya, Queensland, Australia
Monash Health ( Site 0454)
Clayton, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals ( Site 0450)
St Albans, Victoria, Australia
Hospital de Câncer de Recife ( Site 0158)
Recife, Pernambuco, Brazil
Hospital de Caridade de Ijuí ( Site 0150)
Ijuí, Rio Grande do Sul, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição ( Site 0156)
Porto Alegre, Rio Grande do Sul, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)
Florianópolis, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)
São José do Rio Preto, São Paulo, Brazil
COE Ensino e Pesquisa ( Site 0151)
São José dos Campos, São Paulo, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
São Paulo, Brazil
Moncton Hospital - Horizon Health Network ( Site 0011)
Moncton, New Brunswick, Canada
Princess Margaret Cancer Centre ( Site 0001)
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0006)
Montreal, Quebec, Canada
CIDO SpA ( Site 0212)
Temuco, Región de la Araucanía, Chile
Anhui Provincial Cancer Hospital ( Site 0803)
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University ( Site 0813)
Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0824)
Beijing, Beijing Municipality, China
Peking University First Hospital(Daxing Area) ( Site 0838)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 0808)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 0837)
Wanzhou, Chongqing Municipality, China
Fujian Cancer Hospital ( Site 0807)
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 0806)
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 0800)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0812)
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)
Nanning, Guangxi, China
Henan Cancer Hospital ( Site 0822)
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0814)
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University ( Site 0834)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 0826)
Nanchang, Jiangxi, China
Jinan Central Hospital ( Site 0817)
Jinan, Shandong, China
Fudan University Shanghai Cancer Center ( Site 0816)
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Shanxi Medical University ( Site 0843)
Taiyuan, Shanxi, China
Sichuan Cancer hospital. ( Site 0831)
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University ( Site 0845)
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0821)
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)
Wenzhou, Zhejiang, China
Hospital Universitario San Ignacio ( Site 0254)
Bogota, Cundinamarca, Colombia
IMAT S.A.S ( Site 0252)
Montería, Departamento de Córdoba, Colombia
Oncologos Del Occidente ( Site 0255)
Pereira, Risaralda Department, Colombia
Tampere University Hospital ( Site 1001)
Tampere, Pirkanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)
Nice, Alpes-Maritimes, France
Centre François Baclesse ( Site 1061)
Caen, Calvados, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)
Limoges, Limousin, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)
Vandœuvre-lès-Nancy, Lorraine, France
Institut Jean Godinot ( Site 1054)
Reims, Marne, France
Institut de Cancérologie de l'Ouest ( Site 1062)
Angers, Pays de la Loire Region, France
CHU Charles Nicolle ( Site 1066)
Rouen, Seine-Maritime, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)
Avignon, Vaucluse, France
Katholisches Marienkrankenhaus gGmbH ( Site 1103)
Hamburg, Germany
Prince of Wales Hospital. ( Site 0500)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 0501)
Hong Kong, Hong Kong
Rambam Health Care Campus ( Site 1253)
Haifa, Israel
Hadassah Medical Center ( Site 1252)
Jerusalem, Israel
Rabin Medical Center ( Site 1251)
Petah Tikva, Israel
Sheba Medical Center ( Site 1254)
Ramat Gan, Israel
AOU Cagliari ( Site 1306)
Monserrato, Cagliari, Italy
Ospedale San Raffaele. ( Site 1305)
Milan, Italy
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)
Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 1307)
Padova, Italy
Azienda USL della Romagna ( Site 1303)
Ravenna, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)
Verona, Italy
National Cancer Center Hospital East ( Site 0851)
Kashiwa, Chiba, Japan
Teine Keijinkai Hospital ( Site 0864)
Sapporo, Hokkaido, Japan
Kagawa University Hospital ( Site 0861)
Kita-gun, Kagawa-ken, Japan
Tohoku University Hospital ( Site 0853)
Sendai, Miyagi, Japan
Kindai University Hospital ( Site 0854)
Sakai, Osaka, Japan
Saitama Medical University International Medical Center ( Site 0860)
Hidaka, Saitama, Japan
Nippon Medical School Hospital ( Site 0859)
Bunkyo, Tokyo, Japan
National Cancer Center Hospital ( Site 0850)
Chūō, Tokyo, Japan
Cancer Institute Hospital of JFCR ( Site 0863)
Koto, Tokyo, Japan
Chiba Cancer Center ( Site 0858)
Chiba, Japan
Kyushu University Hospital ( Site 0862)
Fukuoka, Japan
Radboudumc ( Site 1354)
Nijmegen, Gelderland, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)
Breda, North Brabant, Netherlands
Amsterdam UMC, locatie VUmc ( Site 1351)
Amsterdam, North Holland, Netherlands
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)
Poznan, Greater Poland Voivodeship, Poland
Institutul Oncologic Cluj ( Site 1502)
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)
Craiova, Dolj, Romania
Fundeni Clinical Institute-Medical Oncology ( Site 1504)
Bucharest, Romania
Institutul Regional de Oncologie ( Site 1505)
Iași, Romania
National Cancer Centre Singapore ( Site 0650)
Singapore, Central Singapore, Singapore
National Cancer Center ( Site 0702)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0705)
Seongnam-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0703)
Suwon, Kyonggi-do, South Korea
Samsung Medical Center ( Site 0708)
Gangnam, Seoul, South Korea
Asan Medical Center ( Site 0707)
Songpa-gu, Seoul, South Korea
Kyungpook National University Chilgok Hospital ( Site 0701)
Buk-Gu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 0706)
Seoul, South Korea
Korea University Guro Hospital ( Site 0704)
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)
Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1551)
Santander, Cantabria, Spain
Hospital Insular de Gran Canaria ( Site 1558)
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Central de Asturias ( Site 1550)
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron ( Site 1553)
Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)
Madrid, Spain
Hospital Clinico San Carlos ( Site 1555)
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)
Seville, Spain
Instituto Valenciano de Oncologia - IVO ( Site 1557)
Valencia, Spain
National Cheng Kung University Hospital ( Site 0754)
Tainan, Taiwan
National Taiwan University Hospital ( Site 0751)
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 0752)
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)
Taoyuan District, Taiwan
MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)
Cherkasy, Cherkasy Oblast, Ukraine
RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)
Chernivtsi, Chernivetska Oblast, Ukraine
MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)
Lviv, Lviv Oblast, Ukraine
MNE "Central City Hospital" ( Site 1711)
Rivne, Rivne Oblast, Ukraine
ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)
Lutsk, Volyn Oblast, Ukraine
Uzhgorod Central City Clinical Hospital ( Site 1700)
Uzhhorod, Zakarpattia Oblast, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)
Kyiv, Ukraine
SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)
Kyiv, Ukraine
LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)
Kyiv, Ukraine
University College London Hospitals ( Site 1750)
London, London, City of, United Kingdom
Churchill Hospital ( Site 1756)
Oxford, Oxfordshire, United Kingdom
The Christie NHS Foundation Trust ( Site 1755)
Manchester, United Kingdom