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RECRUITING
NCT06997497
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

Calderasib

Oral tablet

DRUG

Oxaliplatin

Per label

DRUG

Leucovorin/levofolinate calcium

Per label

DRUG

5-Fluorouracil

Per label

BIOLOGICAL

Cetuximab

Per label

DRUG

Bevacizumab

Per label

DRUG

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