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NCT07617610Recruiting

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

Official recordSimplified version

Summary

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.

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland
Sponsor
Swiss Cancer Institute(Other)
Protocol no.
SAKK 41/23
Conditions
Metastatic Colorectal Cancer, BRAF V600E Mutation
Interventions
Other

Treatments studied

  • Longitudinal translational sampling

Locations · 13

  • Aarau, SwitzerlandKantonsspital AarauRecruiting at this site
  • Baden, SwitzerlandKantonsspital BadenRecruiting at this site
  • Basel, SwitzerlandSt. ClaraspitalRecruiting at this site
  • Basel, SwitzerlandUniversitaetsspital BaselRecruiting at this site
  • Bern, SwitzerlandInselspital BernRecruiting at this site
  • Biel, SwitzerlandSpitalzentrum Biel - MEDIN La TourRecruiting at this site
  • Chur, SwitzerlandKantonsspital GraubündenRecruiting at this site
  • Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
  • Sankt Gallen, SwitzerlandHOCH Health Ostschweiz - Kantonsspital St. GallenRecruiting at this site
  • Solothurn, SwitzerlandBürgerspital SolothurnRecruiting at this site
  • Villars-sur-Glâne, SwitzerlandHFR Freiburg - KantonsspitalRecruiting at this site
  • Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
  • Zurich, SwitzerlandUniversitätsspital Zürich USZRecruiting at this site

In total, worldwide, all 13 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 16, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.