drugset
drugset / Trial / NCT06978400

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

NCT06978400 ↗

Phase 2 Recruiting 64 enrolled Blokhin's Russian Cancer Research Center City Clinical Oncology Hospital No 1 · collabMoscow City Oncology Hospital No. 62 · collabMoscow Multidisciplinary Clinical Center "Kommunarka" · collabThe Loginov MCSC MHD · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-03-01
Primary completion
2027-11-10
Completion
2028-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous
Background Dabrafenib Small molecule 150 mg Oral
Subject Panitumumab Monoclonal antibody 6 mg/kg Intravenous
Background Dabrafenib Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

neoplasm