MedDataX Logo

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: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2030-10-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will have 2 parts.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Adenocarcinoma Rectal Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

MK-1084

Intervention Type DRUG

Oral tablet

Oxaliplatin

Intervention Type DRUG

Per label

Leucovorin/levofolinate calcium

Intervention Type DRUG

Per label

5-Fluorouracil

Intervention Type DRUG

Per label

Cetuximab

Intervention Type BIOLOGICAL

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 Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

Per label

Leucovorin/levofolinate calcium

Intervention Type DRUG

Per label

5-Fluorouracil

Intervention Type DRUG

Per label

Bevacizumab

Intervention Type DRUG

Per label

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MK-1084

Oral tablet

Intervention Type DRUG

Oxaliplatin

Per label

Intervention Type DRUG

Leucovorin/levofolinate calcium

Per label

Intervention Type DRUG

5-Fluorouracil

Per label

Intervention Type DRUG

Cetuximab

Per label

Intervention Type BIOLOGICAL

Bevacizumab

Per label

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Erbitux Avastin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orlando Health Cancer Institute ( Site 0065)

Orlando, Florida, United States

Site Status RECRUITING

Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

Louisville, Kentucky, United States

Site Status RECRUITING

Renown Regional Medical Center ( Site 0056)

Reno, Nevada, United States

Site Status RECRUITING

Miami Valley Hospital South ( Site 0075)

Centerville, Ohio, United States

Site Status RECRUITING

Hospital Italiano de Buenos Aires ( Site 0102)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status RECRUITING

Instituto Alexander Fleming ( Site 0101)

Mar del Plata, Buenos Aires, Argentina

Site Status RECRUITING

Fundacion Estudios Clinicos ( Site 0105)

Rosario, Santa Fe Province, Argentina

Site Status RECRUITING

Hospital Privado Universitario de Córdoba ( Site 0108)

Córdoba, , Argentina

Site Status RECRUITING

Sunshine Coast University Hospital ( Site 0451)

Birtinya, Queensland, Australia

Site Status RECRUITING

Monash Health ( Site 0454)

Clayton, Victoria, Australia

Site Status RECRUITING

Hospital de Câncer de Recife ( Site 0158)

Recife, Pernambuco, Brazil

Site Status RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Anhui Provincial Cancer Hospital ( Site 0803)

Hefei, Anhui, China

Site Status RECRUITING

The First Affiliated Hospital of Xiamen University ( Site 0806)

Xiamen, Fujian, China

Site Status RECRUITING

Sun Yat-Sen University Cancer Center ( Site 0800)

Guangzhou, Guangdong, China

Site Status RECRUITING

Southern Medical University Nanfang Hospital ( Site 0812)

Guangzhou, Guangdong, China

Site Status RECRUITING

Jinan Central Hospital ( Site 0817)

Jinan, Shandong, China

Site Status RECRUITING

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1000)

Helsinki, Uusimaa, Finland

Site Status RECRUITING

Centre François Baclesse ( Site 1061)

Caen, Calvados, France

Site Status RECRUITING

Katholisches Marienkrankenhaus gGmbH ( Site 1103)

Hamburg, , Germany

Site Status RECRUITING

Prince of Wales Hospital. ( Site 0500)

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital ( Site 0501)

Hong Kong, , Hong Kong

Site Status RECRUITING

Rambam Health Care Campus ( Site 1253)

Haifa, , Israel

Site Status RECRUITING

Hadassah Medical Center ( Site 1252)

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center ( Site 1251)

Petah Tikva, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 1254)

Ramat Gan, , Israel

Site Status RECRUITING

National Cancer Center Hospital ( Site 0850)

Chūō, Tokyo, Japan

Site Status RECRUITING

Radboudumc ( Site 1354)

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1352)

Breda, North Brabant, Netherlands

Site Status RECRUITING

Institutul Oncologic Cluj ( Site 1502)

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 1501)

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1500)

Craiova, Dolj, Romania

Site Status RECRUITING

National Cancer Center ( Site 0702)

Goyang-si, Kyonggi-do, South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital ( Site 0705)

Seongnam-si, Kyonggi-do, South Korea

Site Status RECRUITING

The Catholic University of Korea St. Vincent s Hospital ( Site 0703)

Suwon, Kyonggi-do, South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 0708)

Gangnam, Seoul, South Korea

Site Status RECRUITING

Asan Medical Center ( Site 0707)

Songpa-gu, Seoul, South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital ( Site 0701)

Buk-Gu, Taegu-Kwangyokshi, South Korea

Site Status RECRUITING

Seoul National University Hospital ( Site 0706)

Seoul, , South Korea

Site Status RECRUITING

Institut Català d'Oncologia (ICO) - Badalona ( Site 1552)

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 1551)

Santander, Cantabria, Spain

Site Status RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1554)

Madrid, , Spain

Site Status RECRUITING

Hospital Clinico San Carlos ( Site 1555)

Madrid, , Spain

Site Status RECRUITING

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1556)

Seville, , Spain

Site Status RECRUITING

Instituto Valenciano de Oncologia - IVO ( Site 1557)

Valencia, , Spain

Site Status RECRUITING

National Cheng Kung University Hospital ( Site 0754)

Tainan, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital ( Site 0752)

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 0753)

Taoyuan District, , Taiwan

Site Status RECRUITING

MNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of CRC" ( Site 1706)

Cherkasy, Cherkasy Oblast, Ukraine

Site Status RECRUITING

RMNE "Bukovyna Clinical Oncology Center" ( Site 1709)

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status RECRUITING

MNPE "Prykarpattia Clinical Oncology Center of Ivano-Frankivsk Regional Council" ( Site 1701)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status RECRUITING

CNE "Regional Clinical Oncology Center of the Kirovohrad Regional Council" ( Site 1702)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Site Status RECRUITING

MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 1708)

Lviv, Lviv Oblast, Ukraine

Site Status RECRUITING

MNE "Central City Hospital" ( Site 1711)

Rivne, Rivne Oblast, Ukraine

Site Status RECRUITING

ME "Volyn Regional Clinical Hospital" of the VRC ( Site 1712)

Lutsk, Volyn Oblast, Ukraine

Site Status RECRUITING

Uzhgorod Central City Clinical Hospital ( Site 1700)

Uzhhorod, Zakarpattia Oblast, Ukraine

Site Status RECRUITING

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1704)

Kyiv, , Ukraine

Site Status RECRUITING

SI "National Institute of Surgery and Transplantology named after O. O. Shalimov" ( Site 1713)

Kyiv, , Ukraine

Site Status RECRUITING

LLC "MEDICAL CENTER DOBROBUT-CLINIC" ( Site 1703)

Kyiv, , Ukraine

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Brazil China Finland France Germany Hong Kong Israel Japan Netherlands Romania South Korea Spain Taiwan Ukraine

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

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