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 (68) 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 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.

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
Florida
Orlando Health Cancer Institute ( Site 0065)
RECRUITING
Orlando
Kentucky
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
RECRUITING
Louisville
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
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
Brazil
Hospital de Caridade de Ijuí ( Site 0150)
RECRUITING
Ijuí
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
IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)
RECRUITING
São Paulo
China
Southern Medical University Nanfang Hospital ( Site 0812)
RECRUITING
Guangzhou
Sun Yat-Sen University Cancer Center ( Site 0800)
RECRUITING
Guangzhou
Anhui Provincial Cancer Hospital ( Site 0803)
RECRUITING
Hefei
Jinan Central Hospital ( Site 0817)
RECRUITING
Jinan
The First Affiliated Hospital of Xiamen University ( Site 0806)
RECRUITING
Xiamen
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)
RECRUITING
Helsinki
France
Centre François Baclesse ( Site 1061)
RECRUITING
Caen
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
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
Japan
National Cancer Center Hospital ( Site 0850)
RECRUITING
Chūō
Netherlands
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
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
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
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
The Christie NHS Foundation Trust ( Site 1755)
RECRUITING
Manchester
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: 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.
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
Colorectal Cancer
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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