Primary and Acquired Resistance to Targeted Treatment in BRAF V600E-mutated Metastatic Colorectal Cancer

Recruiting now

Conditions studied: Metastatic Colorectal Cancer, BRAF V600E Mutation

In brief

This study prospectively investigates the molecular mechanisms of primary and acquired resistance to standard-of-care BRAF V600E-directed therapy in patients with metastatic colorectal cancer and aims to pre-clinically develop novel strategies to reverse therapy resistance. Clinically approved combination treatment with cetuximab, encorafenib and chemotherapy improves patient outcomes, yet patients eventually experience disease progression. In this prospective multicenter study, tumor tissue, blood, and stool samples will be collected before treatment and at progression, to identify genetic and non-genetic mechanisms of resistance. Additionally, tumor tissue-based in vitro models (patient-derived organoids, PDOs) will be generated and exploited for functional in vitro testing, including genomic and pharmacologic perturbation studies. The overarching goal is to generate knowledge that can help develop new and more effective treatment strategies for future patients.

Key facts

Study ID

NCT07617610

Run by

Swiss Cancer Institute

People needed

30

Starts

2025-05-25

Expected to finish

2030-09-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of unresectable or metastatic BRAF V600E-mutated colorectal cancer
• Planned initiation of treatment with combined anti-EGFR antibody and BRAF inhibitor
• Patients receiving treatment in any line, with or without chemotherapy
• At least one tumor lesion accessible for biopsy
• ECOG performance status 0-2
• Life expectancy of at least 3 months
• Age ≥18 years
• Ability to provide written informed consent

You may not qualify if…

• Medical or surgical contraindication for tumor biopsy
• Active second malignancy (except non-melanoma skin cancer)
• Inability to comply with study procedures (e.g., due to language barriers or cognitive impairment)
• Pregnancy or breastfeeding
• Previous treatment with a BRAF inhibitor

Where it is running

• Kantonsspital Aarau — Aarau, Switzerland (enrolling)
• Kantonsspital Baden — Baden, Switzerland (enrolling)
• St. Claraspital — Basel, Switzerland (enrolling)
• Universitaetsspital Basel — Basel, Switzerland (enrolling)
• Inselspital Bern — Bern, Switzerland (enrolling)
• Spitalzentrum Biel - MEDIN La Tour — Biel, Switzerland (enrolling)
• Kantonsspital Graubünden — Chur, Switzerland (enrolling)
• Luzerner Kantonsspital — Lucerne, Switzerland (enrolling)
• HOCH Health Ostschweiz - Kantonsspital St. Gallen — Sankt Gallen, Switzerland (enrolling)
• Bürgerspital Solothurn — Solothurn, Switzerland (enrolling)
• HFR Freiburg - Kantonsspital — Villars-sur-Glâne, Switzerland (enrolling)
• Kantonsspital Winterthur — Winterthur, Switzerland (enrolling)
• Universitätsspital Zürich USZ — Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.