Understanding why BRAF V600E colorectal cancer stops responding to targeted therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study conducted in Switzerland. Researchers will collect tumor tissue, blood, and stool samples before treatment and at disease progression to identify genetic and non-genetic factors linked to resistance to BRAF V600E-directed therapy. Patient-derived organoids will be created from tumor tissue to test resistance mechanisms in the lab. The goal is to generate knowledge that could guide the development of new strategies to overcome resistance and improve outcomes for future patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Kantonsspital Aarau
  Aarau, Switzerland Recruiting
• Kantonsspital Baden
  Baden, Switzerland Recruiting
• St. Claraspital
  Basel, Switzerland Recruiting
• Universitaetsspital Basel
  Basel, Switzerland Recruiting
• Inselspital Bern
  Bern, Switzerland Recruiting
• Spitalzentrum Biel - MEDIN La Tour
  Biel, Switzerland Recruiting

Study contacts

• Study coordinator: Krista Zackel
• Email: trials@swisscancerinstitute.ch
• Phone: +41313899191

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Becotatug Vedotin plus Pucotenlimab for EGFR-positive metastatic colorectal cancer

  This study tests whether combining becotatug vedotin with pucotenlimab can shrink tumors in adults with colorectal cancer that has returned or spread after at least two prior treatments and whose tumors express EGFR.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07884188

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Immunotherapy plus Simvastatin and Targeted Therapy with Chemotherapy for Advanced Colorectal Cancer

  This trial tests whether adding immune therapy (adbelimumab? actually Adebrelimab) with simvastatin and targeted therapy to standard chemotherapy helps people with metastatic colorectal cancer that is MSI-H/dMMR or MSS/pMMR depending on combination.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu and 1 other locations · NCT07718490

• Fruquintinib treatment in adults with metastatic colorectal cancer in Poland

  This study looks at whether taking fruquintinib by mouth after prior therapies helps adults with metastatic colorectal cancer in Poland live longer before the cancer progresses and overall survival, while also considering quality of life.

  Recruiting at 3 sites Takeda · Poznan, Greater Poland Voivodeship and 9 other locations · NCT07623174

• Second-line combination treatment for MSS metastatic colorectal cancer

  This trial will try folinic acid plus continuous 5-FU with liposomal irinotecan, sometimes combined with cetuximab or bevacizumab, as a second-line option for adults with MSS metastatic colorectal cancer who progressed on or cannot tolerate oxaliplatin-based therapy.

  Recruiting Phase 2 The First Hospital of Jilin University · Changchun, Jilin · NCT07559760

• Comparing Precem-TcT (with or without bevacizumab) versus trifluridine/tipiracil plus bevacizumab for people with previously treated metastatic colorectal cancer

  This trial will see if Precem-TcT, alone or with bevacizumab, helps people with metastatic colorectal cancer who have already received standard chemotherapy, compared with trifluridine/tipiracil plus bevacizumab.

  Recruiting at 116 sites Phase 3 EMD Serono · San Francisco, California and 115 other locations · NCT07549412

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.