A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
NCT ID: NCT06997497
Last Updated: 2026-01-20
Study Results
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Basic Information
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RECRUITING
PHASE3
477 participants
INTERVENTIONAL
2025-07-16
2030-10-27
Brief Summary
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Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding MK-1084 (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. MK-1084 and cetuximab are targeted therapies.
The goals of this study are to learn:
* About the safety of MK-1084 with cetuximab and mFOLFOX6 and if people tolerate the treatments
* If people who receive MK-1084 with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MK-1084 + Cetuximab + mFOLFOX6
Participants will receive MK-1084 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.
MK-1084
Oral tablet
Oxaliplatin
Per label
Leucovorin/levofolinate calcium
Per label
5-Fluorouracil
Per label
Cetuximab
Per label
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.
Oxaliplatin
Per label
Leucovorin/levofolinate calcium
Per label
5-Fluorouracil
Per label
Bevacizumab
Per label
Bevacizumab biosimilar
Per label
Interventions
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MK-1084
Oral tablet
Oxaliplatin
Per label
Leucovorin/levofolinate calcium
Per label
5-Fluorouracil
Per label
Cetuximab
Per label
Bevacizumab
Per label
Bevacizumab biosimilar
Per label
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Orlando Health Cancer Institute ( Site 0065)
Orlando, Florida, United States
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
Louisville, Kentucky, 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
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
Hospital de Câncer de Recife ( Site 0158)
Recife, Pernambuco, Brazil
Hospital de Caridade de Ijuí ( Site 0150)
Ijuí, Rio Grande do Sul, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)
São José do Rio Preto, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
São Paulo, , Brazil
Anhui Provincial Cancer Hospital ( Site 0803)
Hefei, Anhui, 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
Jinan Central Hospital ( Site 0817)
Jinan, Shandong, China
Tampere University Hospital ( Site 1001)
Tampere, Pirkanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
Helsinki, Uusimaa, Finland
Centre François Baclesse ( Site 1061)
Caen, Calvados, 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
National Cancer Center Hospital ( Site 0850)
Chūō, Tokyo, Japan
Radboudumc ( Site 1354)
Nijmegen, Gelderland, Netherlands
Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)
Breda, North Brabant, 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 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
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
The Christie NHS Foundation Trust ( Site 1755)
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1084-012
Identifier Type: OTHER
Identifier Source: secondary_id
KANDLELIT-012
Identifier Type: OTHER
Identifier Source: secondary_id
2024-517232-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1311-8311
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031250265
Identifier Type: REGISTRY
Identifier Source: secondary_id
1084-012
Identifier Type: -
Identifier Source: org_study_id
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