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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)
NCT06997497 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
This study will have 2 parts.
Eligibility criteria
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
* Tumor tissue 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 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
* 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 design
Enrollment target: 477 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-07-16
Estimated completion: 2030-10-27
Last updated: 2026-04-13
Interventions
Drug: CalderasibDrug: OxaliplatinDrug: Leucovorin/levofolinate calciumDrug: 5-FluorouracilBiological: CetuximabDrug: BevacizumabDrug: Bevacizumab biosimilar
Primary outcomes
- • Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Up to approximately 28 days)
- • Part 1: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months)
- • Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 44 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (148)
Los Angeles Hematology Oncology Medical Group ( Site 0084)Recruiting
Los Angeles, California, United States
Florida Cancer Specialists - South ( Site 7002)Recruiting
Fort Myers, Florida, United States
Orlando Health Cancer Institute ( Site 0065)Recruiting
Orlando, Florida, United States
Florida Cancer Specialists - North ( Site 7001)Recruiting
St. Petersburg, Florida, United States
Florida Cancer Specialists - East ( Site 7000)Recruiting
West Palm Beach, Florida, United States
University of Iowa ( Site 0074)Recruiting
Iowa City, Iowa, United States
University of Kentucky ( Site 0055)Recruiting
Lexington, Kentucky, United States
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)Recruiting
Louisville, Kentucky, United States
Greater Baltimore Medical Center ( Site 0068)Recruiting
Baltimore, Maryland, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)Recruiting
Billings, Montana, United States
University Of Nebraska Medical Center ( Site 0078)Recruiting
Omaha, Nebraska, United States
Renown Regional Medical Center ( Site 0056)Recruiting
Reno, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)Recruiting
Hackensack, New Jersey, United States
Miami Valley Hospital South ( Site 0075)Recruiting
Centerville, Ohio, United States
Community Cancer Trials of Utah ( Site 0086)Recruiting
Ogden, Utah, United States
University of Virginia ( Site 0080)Recruiting
Charlottesville, Virginia, United States
Hospital Italiano de Buenos Aires ( Site 0102)Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0101)Recruiting
Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos ( Site 0105)Recruiting
Rosario, Santa Fe Province, Argentina
Hospital Privado Universitario de Córdoba ( Site 0108)Recruiting
Córdoba, Argentina
Sunshine Coast University Hospital ( Site 0451)Recruiting
Birtinya, Queensland, Australia
Monash Health ( Site 0454)Recruiting
Clayton, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals ( Site 0450)Recruiting
St Albans, Victoria, Australia
Hospital de Câncer de Recife ( Site 0158)Recruiting
Recife, Pernambuco, Brazil
Hospital de Caridade de Ijuí ( Site 0150)Recruiting
Ijuí, Rio Grande do Sul, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)Recruiting
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição ( Site 0156)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)Recruiting
Florianópolis, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)Recruiting
Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)Recruiting
São José do Rio Preto, São Paulo, Brazil
COE Ensino e Pesquisa ( Site 0151)Recruiting
São José dos Campos, São Paulo, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)Recruiting
São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)Recruiting
São Paulo, Brazil
Cancercare Manitoba ( Site 0009)Recruiting
Winnipeg, Manitoba, Canada
Moncton Hospital - Horizon Health Network ( Site 0011)Recruiting
Moncton, New Brunswick, Canada
Princess Margaret Cancer Centre ( Site 0001)Recruiting
Toronto, Ontario, Canada
Jewish General Hospital ( Site 0006)Recruiting
Montreal, Quebec, Canada
CIDO SpA ( Site 0212)Recruiting
Temuco, Araucania, Chile
Anhui Provincial Cancer Hospital ( Site 0803)Recruiting
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University ( Site 0813)Recruiting
Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 0824)Recruiting
Beijing, Beijing Municipality, China
Peking University First Hospital(Daxing Area) ( Site 0838)Recruiting
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 0808)Recruiting
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital ( Site 0837)Recruiting
Wanzhou, Chongqing Municipality, China
Fujian Cancer Hospital ( Site 0807)Recruiting
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 0806)Recruiting
Xiamen, Fujian, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)Recruiting
Xiamen, Fujian, China
Sun Yat-Sen University Cancer Center ( Site 0800)Recruiting
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0812)Recruiting
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)Recruiting
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)Recruiting
Nanning, Guangxi, China
Henan Cancer Hospital ( Site 0822)Recruiting
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)Recruiting
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 0814)Recruiting
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University ( Site 0834)Recruiting
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)Recruiting
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 0826)Recruiting
Nanchang, Jiangxi, China
Jinan Central Hospital ( Site 0817)Recruiting
Jinan, Shandong, China
Fudan University Shanghai Cancer Center ( Site 0816)Recruiting
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Shanxi Medical University ( Site 0843)Recruiting
Taiyuan, Shanxi, China
Sichuan Cancer hospital. ( Site 0831)Recruiting
Chengdu, Sichuan, China
First Affiliated Hospital of Kunming Medical University ( Site 0845)Recruiting
Kunming, Yunnan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)Recruiting
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 0821)Recruiting
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)Recruiting
Wenzhou, Zhejiang, China
Hospital Universitario San Ignacio ( Site 0254)Recruiting
Bogota, Cundinamarca, Colombia
IMAT S.A.S ( Site 0252)Recruiting
Montería, Departamento de Córdoba, Colombia
Oncologos Del Occidente ( Site 0255)Recruiting
Pereira, Risaralda Department, Colombia
Tampere University Hospital ( Site 1001)Recruiting
Tampere, Pirkanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)Recruiting
Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)Recruiting
Nice, Alpes-Maritimes, France
Centre François Baclesse ( Site 1061)Recruiting
Caen, Calvados, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)Recruiting
Limoges, Limousin, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)Recruiting
Vandœuvre-lès-Nancy, Lorraine, France
Institut Jean Godinot ( Site 1054)Recruiting
Reims, Marne, France
Institut de Cancérologie de l'Ouest ( Site 1062)Recruiting
Angers, Pays de la Loire Region, France
CHU Charles Nicolle ( Site 1066)Recruiting
Rouen, Seine-Maritime, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)Recruiting
Avignon, Vaucluse, France
Katholisches Marienkrankenhaus gGmbH ( Site 1103)Recruiting
Hamburg, Germany
Prince of Wales Hospital. ( Site 0500)Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 0501)Recruiting
Hong Kong, Hong Kong
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)Recruiting
Pécs, Baranya, Hungary
Rambam Health Care Campus ( Site 1253)Recruiting
Haifa, Israel
Hadassah Medical Center ( Site 1252)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 1251)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 1254)Recruiting
Ramat Gan, Israel
AOU Cagliari ( Site 1306)Recruiting
Monserrato, Cagliari, Italy
Ospedale San Raffaele. ( Site 1305)Recruiting
Milan, Italy
Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1302)Recruiting
Naples, Italy
Istituto Oncologico Veneto IRCCS ( Site 1307)Recruiting
Padova, Italy
Azienda USL della Romagna ( Site 1303)Recruiting
Ravenna, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)Recruiting
Verona, Italy
National Cancer Center Hospital East ( Site 0851)Recruiting
Kashiwa, Chiba, Japan
Teine Keijinkai Hospital ( Site 0864)Recruiting
Sapporo, Hokkaido, Japan
Kagawa University Hospital ( Site 0861)Recruiting
Kita-gun, Kagawa-ken, Japan
Tohoku University Hospital ( Site 0853)Recruiting
Sendai, Miyagi, Japan
Kindai University Hospital ( Site 0854)Recruiting
Sakai, Osaka, Japan
Saitama Medical University International Medical Center ( Site 0860)Recruiting
Hidaka, Saitama, Japan
Nippon Medical School Hospital ( Site 0859)Recruiting
Bunkyo, Tokyo, Japan
National Cancer Center Hospital ( Site 0850)Recruiting
Chūō, Tokyo, Japan
Cancer Institute Hospital of JFCR ( Site 0863)Recruiting
Koto, Tokyo, Japan
Chiba Cancer Center ( Site 0858)Recruiting
Chiba, Japan
Kyushu University Hospital ( Site 0862)Recruiting
Fukuoka, Japan
Radboudumc ( Site 1354)Recruiting
Nijmegen, Gelderland, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)Recruiting
Breda, North Brabant, Netherlands
Amsterdam UMC, locatie VUmc ( Site 1351)Recruiting
Amsterdam, North Holland, Netherlands
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)Recruiting
Poznan, Greater Poland Voivodeship, Poland
Institutul Oncologic Cluj ( Site 1502)Recruiting
Cluj-Napoca, Cluj, Romania
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)Recruiting
Cluj-Napoca, Cluj, Romania
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)Recruiting
Craiova, Dolj, Romania
Fundeni Clinical Institute-Medical Oncology ( Site 1504)Recruiting
Bucharest, Romania
Institutul Regional de Oncologie ( Site 1505)Recruiting
Iași, Romania
National Cancer Centre Singapore ( Site 0650)Recruiting
Singapore, Central Singapore, Singapore
National Cancer Center ( Site 0702)Recruiting
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0705)Recruiting
Seongnam-si, Kyonggi-do, South Korea
The Catholic University of Korea St. Vincent s Hospital ( Site 0703)Recruiting
Suwon, Kyonggi-do, South Korea
Samsung Medical Center ( Site 0708)Recruiting
Gangnam, Seoul, South Korea
Asan Medical Center ( Site 0707)Recruiting
Songpa-gu, Seoul, South Korea
Kyungpook National University Chilgok Hospital ( Site 0701)Recruiting
Buk-Gu, Taegu-Kwangyokshi, South Korea
Seoul National University Hospital ( Site 0706)Recruiting
Seoul, South Korea
Korea University Guro Hospital ( Site 0704)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)Recruiting
Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1551)Recruiting
Santander, Cantabria, Spain
Hospital Insular de Gran Canaria ( Site 1558)Recruiting
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Central de Asturias ( Site 1550)Recruiting
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron ( Site 1553)Recruiting
Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)Recruiting
Madrid, Spain
Hospital Clinico San Carlos ( Site 1555)Recruiting
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)Recruiting
Seville, Spain
Instituto Valenciano de Oncologia - IVO ( Site 1557)Recruiting
Valencia, Spain
National Cheng Kung University Hospital ( Site 0754)Recruiting
Tainan, Taiwan
National Taiwan University Hospital ( Site 0751)Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 0752)Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)Recruiting
Taoyuan District, Taiwan
MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)Recruiting
Cherkasy, Cherkasy Oblast, Ukraine
RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)Recruiting
Chernivtsi, Chernivetska Oblast, Ukraine
MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)Recruiting
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)Recruiting
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)Recruiting
Lviv, Lviv Oblast, Ukraine
MNE "Central City Hospital" ( Site 1711)Recruiting
Rivne, Rivne Oblast, Ukraine
ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)Recruiting
Lutsk, Volyn Oblast, Ukraine
Uzhgorod Central City Clinical Hospital ( Site 1700)Recruiting
Uzhhorod, Zakarpattia Oblast, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)Recruiting
Kyiv, Ukraine
SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)Recruiting
Kyiv, Ukraine
LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)Recruiting
Kyiv, Ukraine
University College London Hospitals ( Site 1750)Recruiting
London, London, City of, United Kingdom
Churchill Hospital ( Site 1756)Recruiting
Oxford, Oxfordshire, United Kingdom
The Christie NHS Foundation Trust ( Site 1755)Recruiting
Manchester, United Kingdom