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

Recruitingn/aAges 18 Years - anyAllSwiss Cancer Institute
NCT07617610 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Longitudinal translational sampling
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Where

13 sites
Kantonsspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
St. Claraspital
Basel, Switzerland
Universitaetsspital Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Spitalzentrum Biel - MEDIN La Tour
Biel, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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