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)
Status: Recruiting
Location: See all (148) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
California
Los Angeles Hematology Oncology Medical Group ( Site 0084)
RECRUITING
Los Angeles
Florida
Florida Cancer Specialists - South ( Site 7002)
RECRUITING
Fort Myers
Orlando Health Cancer Institute ( Site 0065)
RECRUITING
Orlando
Florida Cancer Specialists - North ( Site 7001)
RECRUITING
St. Petersburg
Florida Cancer Specialists - East ( Site 7000)
RECRUITING
West Palm Beach
Iowa
University of Iowa ( Site 0074)
RECRUITING
Iowa City
Kentucky
University of Kentucky ( Site 0055)
RECRUITING
Lexington
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
RECRUITING
Louisville
Maryland
Greater Baltimore Medical Center ( Site 0068)
RECRUITING
Baltimore
Montana
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)
RECRUITING
Billings
Nebraska
University Of Nebraska Medical Center ( Site 0078)
RECRUITING
Omaha
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
RECRUITING
Hackensack
Nevada
Renown Regional Medical Center ( Site 0056)
RECRUITING
Reno
Ohio
Miami Valley Hospital South ( Site 0075)
RECRUITING
Centerville
Utah
Community Cancer Trials of Utah ( Site 0086)
RECRUITING
Ogden
Virginia
University of Virginia ( Site 0080)
RECRUITING
Charlottesville
Other Locations
Argentina
Hospital Italiano de Buenos Aires ( Site 0102)
RECRUITING
Ciudad Autonoma De Buenos Aires
Hospital Privado Universitario de Córdoba ( Site 0108)
RECRUITING
Córdoba
Instituto Alexander Fleming ( Site 0101)
RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos ( Site 0105)
RECRUITING
Rosario
Australia
Sunshine Coast University Hospital ( Site 0451)
RECRUITING
Birtinya
Monash Health ( Site 0454)
RECRUITING
Clayton
Western Health-Sunshine & Footscray Hospitals ( Site 0450)
RECRUITING
St Albans
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)
RECRUITING
Barretos
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)
RECRUITING
Florianópolis
Hospital de Caridade de Ijuí ( Site 0150)
RECRUITING
Ijuí
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)
RECRUITING
Passo Fundo
Hospital Nossa Senhora da Conceição ( Site 0156)
RECRUITING
Porto Alegre
Hospital de Câncer de Recife ( Site 0158)
RECRUITING
Recife
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)
RECRUITING
São José Do Rio Preto
COE Ensino e Pesquisa ( Site 0151)
RECRUITING
São José Dos Campos
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
RECRUITING
São Paulo
Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)
RECRUITING
São Paulo
Canada
Moncton Hospital - Horizon Health Network ( Site 0011)
RECRUITING
Moncton
Jewish General Hospital ( Site 0006)
RECRUITING
Montreal
Princess Margaret Cancer Centre ( Site 0001)
RECRUITING
Toronto
Cancercare Manitoba ( Site 0009)
RECRUITING
Winnipeg
Chile
CIDO SpA ( Site 0212)
RECRUITING
Temuco
China
Peking Union Medical College Hospital ( Site 0824)
RECRUITING
Beijing
Peking University First Hospital(Daxing Area) ( Site 0838)
RECRUITING
Beijing
The Third Xiangya Hospital of Central South University ( Site 0834)
RECRUITING
Changsha
Sichuan Cancer hospital. ( Site 0831)
RECRUITING
Chengdu
Chongqing University Cancer Hospital ( Site 0808)
RECRUITING
Chongqing
Fujian Cancer Hospital ( Site 0807)
RECRUITING
Fuzhou
Southern Medical University Nanfang Hospital ( Site 0812)
RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center ( Site 0800)
RECRUITING
Guangzhou
The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 0828)
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 0801)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 0821)
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital ( Site 0803)
RECRUITING
Hefei
The Second Affiliated Hospital of Anhui Medical University ( Site 0813)
RECRUITING
Hefei
Jinan Central Hospital ( Site 0817)
RECRUITING
Jinan
First Affiliated Hospital of Kunming Medical University ( Site 0845)
RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University ( Site 0826)
RECRUITING
Nanchang
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0825)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 0804)
RECRUITING
Nanning
Fudan University Shanghai Cancer Center ( Site 0816)
RECRUITING
Shanghai
First Affiliated Hospital of Shanxi Medical University ( Site 0843)
RECRUITING
Taiyuan
Chongqing University Three Gorges Hospital ( Site 0837)
RECRUITING
Wanzhou
The First Affiliated Hospital of Wenzhou Medical University ( Site 0840)
RECRUITING
Wenzhou
Hubei Cancer Hospital ( Site 0814)
RECRUITING
Wuhan
Tongji Hospital Tongji Medical,Science & Technology ( Site 0839)
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University ( Site 0806)
RECRUITING
Xiamen
Zhongshan Hospital Affiliated to Xiamen University ( Site 1902)
RECRUITING
Xiamen
Henan Cancer Hospital ( Site 0822)
RECRUITING
Zhengzhou
Colombia
Hospital Universitario San Ignacio ( Site 0254)
RECRUITING
Bogota
IMAT S.A.S ( Site 0252)
RECRUITING
Montería
Oncologos Del Occidente ( Site 0255)
RECRUITING
Pereira
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
RECRUITING
Helsinki
Tampere University Hospital ( Site 1001)
RECRUITING
Tampere
France
Institut de Cancérologie de l'Ouest ( Site 1062)
RECRUITING
Angers
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1065)
RECRUITING
Avignon
Centre François Baclesse ( Site 1061)
RECRUITING
Caen
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1064)
RECRUITING
Limoges
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1058)
RECRUITING
Nice
Institut Jean Godinot ( Site 1054)
RECRUITING
Reims
CHU Charles Nicolle ( Site 1066)
RECRUITING
Rouen
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 1053)
RECRUITING
Vandœuvre-lès-nancy
Germany
Katholisches Marienkrankenhaus gGmbH ( Site 1103)
RECRUITING
Hamburg
Hong Kong Special Administrative Region
Prince of Wales Hospital. ( Site 0500)
RECRUITING
Hong Kong
Queen Mary Hospital ( Site 0501)
RECRUITING
Hong Kong
Hungary
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1204)
RECRUITING
Pécs
Israel
Rambam Health Care Campus ( Site 1253)
RECRUITING
Haifa
Hadassah Medical Center ( Site 1252)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1251)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1254)
RECRUITING
Ramat Gan
Italy
Ospedale San Raffaele. ( Site 1305)
RECRUITING
Milan
AOU Cagliari ( Site 1306)
RECRUITING
Monserrato
Azienda Ospedaliera Universitaria dell'Università Luigi Van-UOC Oncoematologia ( Site 1302)
RECRUITING
Naples
Istituto Oncologico Veneto IRCCS ( Site 1307)
RECRUITING
Padova
Azienda USL della Romagna ( Site 1303)
RECRUITING
Ravenna
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 1304)
RECRUITING
Verona
Japan
Nippon Medical School Hospital ( Site 0859)
RECRUITING
Bunkyo
Chiba Cancer Center ( Site 0858)
RECRUITING
Chiba
National Cancer Center Hospital ( Site 0850)
RECRUITING
Chūō
Kyushu University Hospital ( Site 0862)
RECRUITING
Fukuoka
Saitama Medical University International Medical Center ( Site 0860)
RECRUITING
Hidaka
National Cancer Center Hospital East ( Site 0851)
RECRUITING
Kashiwa
Kagawa University Hospital ( Site 0861)
RECRUITING
Kita-gun
Cancer Institute Hospital of JFCR ( Site 0863)
RECRUITING
Koto
Kindai University Hospital ( Site 0854)
RECRUITING
Sakai
Teine Keijinkai Hospital ( Site 0864)
RECRUITING
Sapporo
Tohoku University Hospital ( Site 0853)
RECRUITING
Sendai
Netherlands
Amsterdam UMC, locatie VUmc ( Site 1351)
RECRUITING
Amsterdam
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)
RECRUITING
Breda
Radboudumc ( Site 1354)
RECRUITING
Nijmegen
Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 1457)
RECRUITING
Poznan
Republic of Korea
Kyungpook National University Chilgok Hospital ( Site 0701)
RECRUITING
Buk-gu
Samsung Medical Center ( Site 0708)
RECRUITING
Gangnam
National Cancer Center ( Site 0702)
RECRUITING
Goyang-si
Seoul National University Bundang Hospital ( Site 0705)
RECRUITING
Seongnam-si
Korea University Guro Hospital ( Site 0704)
RECRUITING
Seoul
Seoul National University Hospital ( Site 0706)
RECRUITING
Seoul
Asan Medical Center ( Site 0707)
RECRUITING
Songpa-gu
The Catholic University of Korea St. Vincent s Hospital ( Site 0703)
RECRUITING
Suwon
Romania
Fundeni Clinical Institute-Medical Oncology ( Site 1504)
RECRUITING
Bucharest
Institutul Oncologic Cluj ( Site 1502)
RECRUITING
Cluj-napoca
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)
RECRUITING
Craiova
Institutul Regional de Oncologie ( Site 1505)
RECRUITING
Iași
Singapore
National Cancer Centre Singapore ( Site 0650)
RECRUITING
Singapore
Spain
Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron ( Site 1553)
RECRUITING
Barcelona
Hospital Insular de Gran Canaria ( Site 1558)
RECRUITING
Las Palmas De Gran Canaria
Hospital Clinico San Carlos ( Site 1555)
RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)
RECRUITING
Madrid
Hospital Universitario Central de Asturias ( Site 1550)
RECRUITING
Oviedo
Hospital Universitario Marqués de Valdecilla ( Site 1551)
RECRUITING
Santander
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)
RECRUITING
Seville
Instituto Valenciano de Oncologia - IVO ( Site 1557)
RECRUITING
Valencia
Taiwan
National Cheng Kung University Hospital ( Site 0754)
RECRUITING
Tainan
National Taiwan University Hospital ( Site 0751)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 0752)
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)
RECRUITING
Taoyuan District
Ukraine
MNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC ( Site 1706)
RECRUITING
Cherkasy
RMNE Bukovyna Clinical Oncology Center ( Site 1709)
RECRUITING
Chernivtsi
MNPE Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council ( Site 1701)
RECRUITING
Ivano-frankivsk
CNE Regional Clinical Oncology Center of the Kirovohrad Regional Council ( Site 1702)
RECRUITING
Kropyvnytskyi
LLC MEDICAL CENTER DOBROBUT-CLINIC ( Site 1703)
RECRUITING
Kyiv
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 1704)
RECRUITING
Kyiv
SI National Institute of Surgery and Transplantology named after O. O. Shalimov ( Site 1713)
RECRUITING
Kyiv
ME Volyn Regional Clinical Hospital of the VRC ( Site 1712)
RECRUITING
Lutsk
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)
RECRUITING
Lviv
MNE Central City Hospital ( Site 1711)
RECRUITING
Rivne
Uzhgorod Central City Clinical Hospital ( Site 1700)
RECRUITING
Uzhhorod
United Kingdom
University College London Hospitals ( Site 1750)
RECRUITING
London
The Christie NHS Foundation Trust ( Site 1755)
RECRUITING
Manchester
Churchill Hospital ( Site 1756)
RECRUITING
Oxford
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2030-10-27
Participants
Target number of participants: 477
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC