Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

Brain metastases in patients with advanced and metastatic melanoma are a frequent complication and a significant cause of morbidity and mortality in this patient population. As the incidence of brain metastases continues to increase in patients with metastatic melanoma, it is urgent that the investigators identify effective therapies. ENCEFALO is a Phase II, single arm, multicentre clinical trial designed to evaluate the activity of encorafenib plus binimetinib followed by cemiplimab and fianlimab in patients with BRAF mutated melanoma and symptomatic brain metastases, following the simon des

Trial Details

NCT ID
NCT06887088
Phase
PHASE2
Sponsor
Grupo Español Multidisciplinar de Melanoma
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Encorafenib + Binimetinib
  • cemiplimab+fianlimab
Locations (sample)
  • A Coruña, A Coruña, Spain|43.37135,-8.396
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899

Key Eligibility Criteria

  • Patients eligible for inclusion in this study must meet all the following criteria:
  • Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
  • Histologically confirmed diagnosis of unresectable metastatic BRAF-mutated melanoma (stage IV, AJCC v9), with one or more brain metastases with a d…
  • Patients with brain metastasis that debut as symptomatic, regardless of corticosteroid use. The definition of symptoms will be:

For full eligibility, visit ClinicalTrials.gov.

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