Actively Recruiting
A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
Led by Blokhin's Russian Cancer Research Center · Updated on 2025-05-18
64
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
Sponsors
B
Blokhin's Russian Cancer Research Center
Lead Sponsor
C
City Clinical Oncology Hospital No 1
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma with MSS and BRAF V600E mutation
- Metastatic inoperable colorectal cancer
- Adequate blood and organ function
- Measurable or evaluable disease by RECIST v1.1 criteria
- No prior systemic treatment for colorectal cancer, except progression after adjuvant chemo if later than 12 months
- Primary tumor removed or asymptomatic
- No grade 2 or higher neuropathy
- Absence of tumor MSI or dMMR
- ECOG performance status 0-2
You will not qualify if you...
- More than two prior lines of treatment (except progression within 12 months after adjuvant/perioperative chemo with oxaliplatin and fluoropyrimidines)
- Other active malignancies except treated basal cell carcinoma or cervical cancer in situ within 5 years
- Pregnant or breastfeeding women
- Patients refusing adequate contraception
- HIV infection
- Life expectancy less than 3 months
- Any condition preventing participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Blokhin's Russian Cancer Research Center
Moscow, Russia, 115193
Actively Recruiting
Research Team
M
Mikhail Fedyanin MD
CONTACT
E
Evgenia Kuzmina MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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