New hope for melanoma brain metastases: Two-Step treatment trial launches

NCT ID NCT06887088

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing a two-step treatment for people with BRAF-mutated melanoma that has spread to the brain and is causing symptoms. First, participants take two targeted pills (encorafenib and binimetinib) for about two months. Then, they receive two immunotherapy drugs (cemiplimab and fianlimab) intravenously every three weeks for up to two years. The goal is to see if this approach can keep brain tumors from growing for at least six months in more patients than historical treatments.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
encorafenib, binimetinib, cemiplimab, and fianlimab
What this could lead to
If successful, this could offer a new treatment option for people with BRAF-mutated melanoma that has spread to the brain and is causing symptoms.
What could go wrong
This is a small, early-phase trial with only 33 participants and no comparison group. The treatment may not work better than existing options, and side effects from the drug combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clinico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Murcia, 30120, Spain

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, A Coruña, 15006, Spain

  • Hospital Clinico San Carlos

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Barcelona, 08036, Spain

  • Hospital Clínico Universitario Valencia.

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46014, Spain

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, Málaga, 29010, Spain

  • Hospital Universitario Gregorio Marañon

    NOT_YET_RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Puerta del Hierro

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario San Pedro de Alcántara

    RECRUITING

    Cáceres, Cáceres, 10003, Spain

  • Hospital Universitario Vall d´Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, Burgos, 09006, Spain

  • Hospital Virgen de la Macarena (Sevilla)

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Instituto Catalán de Oncología - Hospital Duran i Reynals

    RECRUITING

    Barcelona, Barcelona, 08908, Spain

  • Onkologikoa (Donostia)

    RECRUITING

    Donostia / San Sebastian, Donostia, 20014, Spain

  • Quiron Dexeus - IOR

    RECRUITING

    Barcelona, Barcelona, 08028, Spain

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