NCT06978400RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 64 (estimated)
First submitted: 3 May 2025
Start date: 1 Mar 2025
Primary completion date: 10 Nov 2027
Lead sponsor: Blokhin's Russian Cancer Research Center
Diseases: Colorectal cancer
NCT number: NCT06978400

What you commit to

Study type: Interventional · Phase 2
Planned participants: 64
From 1 Mar 2025 to the primary completion date, 10 Nov 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.

Other illness

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).
HIV-infected patients.
The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.

Other

Pregnant and breastfeeding women.
Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
Patients with a life expectancy of less than 3 months.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Blokhin's Russian Cancer Research Center Coordinator of this site? Confirm its status	Moscow	Russia	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.