A Study to Characterize Encorafenib Plus Cetuximab as Rechallenge Treatment for BRAF V600E-mutant Metastatic Colorectal Cancer Patients After Previous Therapy With BRAF Inhibitors-based Combinations

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT07178717
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colo-rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rechalange with bevacizumab + encorafenib — DRUG
    Patients will receive encorafenib 300mg once daily plus cetuximab 500mg/m2 every 2 weeks until disease progression, unacceptable toxicity, patient request, physician's decision to withdraw treatment, subsequent anticancer therapy or death.

Study Details

This is an open-label, unicentre, single-arm Phase 2 study of encorafenib and cetuximab as rechallenge treatment in patients with BRAF V600E-mutant metastatic colorectal cancer after previous therapy with BRAF inhibitors-based combinations. The study aims to evaluate the antitumor activity of encorafenib plus cetuximab as a rechallenge strategy measured by progression-free survival rate at 4 months. Eligible patients (a total of 25) will receive encorafenib 300 mg (four 75 mg capsules) once daily (q.d) in 28-day cycles plus intravenous cetuximab at 500 mg/m2 every 2 weeks (Q2W). Treatment will be administered until progression, unacceptable toxicity, patient request, physician's decision or subsequent anticancer therapy.

Key Dates

First listed
Sep 17, 2025
Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + encorafenib

Primary Outcome Measure

Progression free survival [ Time Frame: 4 months since the start of treatment ]

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