OncoMatch/Clinical Trials/NCT06978400

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

Is NCT06978400 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy for neoplasms.

Phase 2RecruitingBlokhin's Russian Cancer Research CenterNCT06978400Data as of May 2026

Treatment: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy — 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.

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Extracted eligibility criteria

Biomarker criteria

Required: BRAF V600E mutation

BRAF V600E mutation

Required: MSH2 microsatellite stable

contains MSS

Required: MLH1 microsatellite stable

contains MSS

Required: MSH6 microsatellite stable

contains MSS

Required: PMS2 microsatellite stable

contains MSS

Required: MLH1 wild-type (absence of dMMR)

Absence of tumor MSI or dMMR

Required: MSH2 wild-type (absence of dMMR)

Absence of tumor MSI or dMMR

Required: MSH6 wild-type (absence of dMMR)

Absence of tumor MSI or dMMR

Required: PMS2 wild-type (absence of dMMR)

Absence of tumor MSI or dMMR

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Max 2 prior lines

Lab requirements

Blood counts

adequate function of hematopoiesis

Kidney function

adequate function of basic indicators of internal organs

Liver function

adequate function of basic indicators of internal organs

Adequate function of hematopoiesis and basic indicators of internal organs

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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