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A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer

NCT06978400•Blokhin's Russian Cancer Research Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS. Participants in this study will receive one of the following study treatments: These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy. The study team will monitor how each participant responds to the study treatment for up to about 3 years.

Detailed Description

The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
•Metastatic inoperable colorectal cancer
•Adequate function of hematopoiesis and basic indicators of internal organs
•Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
•Lacking antitumor systemic treatment for colorectal cancer.
•Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
•The primary tumor is removed or asymptomatic.
•Absence of grade 2 or higher neuropathy.
•Absence of tumor MSI or dMMR.
•ECOG PS 0-2

Exclusion Criteria

•Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable).
•Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.
•Pregnant and breastfeeding women.
•Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
•HIV-infected patients.
•Patients with a life expectancy of less than 3 months.
•The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.

Locations (1)

Blokhin's Russian Cancer Research Center

Moscow, Russia

Key Dates

Start Date

March 1, 2025

Primary Completion Date

November 10, 2027

Completion Date

July 10, 2028

Last Updated

May 18, 2025

Enrollment

ESTIMATED participants

Conditions

Neoplasms

Interventions

mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy

DRUG

Contacts

Mikhail Fedyanin MD

CONTACT

+7 905 704-33-18 fedianinmu@mail.ru

Evgenia Kuzmina MD

CONTACT

+7 9824012681 kuz011@mail.ru

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Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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