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New Three-Drug cocktail takes on tough melanoma

NCT ID NCT05926960

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether a three-drug combination (encorafenib, binimetinib, and pembrolizumab) works better than a two-drug combo (ipilimumab and nivolumab) for people with advanced melanoma that has a BRAF mutation and has already been treated with anti-PD-1 therapy. The trial was terminated early after enrolling only 38 participants, so the results are limited. The goal was to see which approach shrinks tumors more effectively and helps people live longer without their cancer growing.

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, and pembrolizumab (drug combination)
What this could lead to
If this combination works better than the standard two-drug approach, it could offer a new treatment option for people with advanced melanoma that has a BRAF mutation and has stopped responding to initial immunotherapy.
What could go wrong
This trial was terminated early with only 38 participants, so results are limited and may not be reliable. Combining three drugs also raises the risk of more severe side effects.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

38 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants ≥18 years of age at the time of informed consent. * Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition. * Documented evidence of a BRAF V600E or V600K mutation. * Availability of adequate tumor tissue (archival or newly obtained; block or slides) to submit to the sponsor central laboratory(ies) during the screening period for central biomarker analyses . * Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab) * Must have anti-PD-1 resistant disease (primary or secondary) with confirmed disease progression per RECIST v1.1 either during or after receipt of an approved anti-PD-1 monotherapy (ie, nivolumab or pembrolizumab) for melanoma, defined according to the SITC Immunotherapy Resistance Taskforce (Kluger et al, 2020). * Have at least one measurable lesion per RECIST v1.1. * ECOG PS of 0-1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging. Exclusion Criteria: * Mucosal or ocular melanoma. * Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment with chronic systemic steroid therapy or any other form of immunosuppressive therapy within the past 2 years. * Clinically significant cardiovascular diseases. * History of thromboembolic or cerebrovascular events ≤12 weeks prior to randomization. * History or current evidence of RVO or current risk factors for RVO. * Concurrent neuromuscular disorder that is associated with the potential of elevated CK. * Active bacterial, fungal, or viral infection requiring systemic therapeutic treatment within 2 weeks prior to randomization. * Current non-infectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids. * Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases. * Participants who permanently discontinued prior anti-PD-1 therapy due to toxicity or will be unable to tolerate combination therapy based on investigator judgement are excluded. * Prior treatment with ipilimumab; prior combined immunotherapy blockade with anti-PD-1/L-1; prior treatment with a BRAFi and/or MEKi; or previous administration of an investigational anti-cancer agent for the adjuvant or first-line treatment of melanoma prior to randomization.

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Conditions

The condition(s) this trial relates to.

melanoma skin neoplasm

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127, Italy

  • AO Santa Maria della Misericordia

    Perugia, Umbria, 06132, Italy

  • Azienda Ospedaliero Universitaria Senese

    Siena, Tuscany, 53100, Italy

  • Fachklinik Hornheide

    Münster, North Rhine-Westphalia, 48157, Germany

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario de Valencia

    Valencia, Valenciana, Comunitat, 46014, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena

    Rome, ROMA, 00144, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128, Italy

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060, Italy

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • Neovizia, s.r.o.

    Bratislava, 85101, Slovakia

  • Pratia MCM Krakow

    Krakow, 30-727, Poland

  • Universitaetsklinikum Essen

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

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