Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for melanoma brain metastases? early trial tests drug combos

NCT ID NCT04700072

Disease control Sponsor: Merck Sharp & Dohme LLC 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed phase 1/2 trial tested the safety and effectiveness of pembrolizumab (Keytruda) alone or combined with other drugs (quavonlimab or lenvatinib) in 56 people with melanoma that had spread to the brain. Participants had not received steroids recently and were neurologically stable. The goal was to see if these combinations could shrink tumors better than current options.

What this could mean

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

Active substance
Pembrolizumab (Keytruda) with or without quavonlimab or lenvatinib
What this could lead to
If successful, this could point toward better treatment options for melanoma that has spread to the brain.
What could go wrong
This is an early-phase trial with only 56 participants, so results may not apply to everyone. Some treatment arms were discontinued, and side effects are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

56 people

The number who actually took part.

Started

May 2021

Finished

Oct 2025

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 to 120 years

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: * Has American Joint Committee on Cancer (AJCC) Stage IV, M1D melanoma * Is neurologically asymptomatic from brain metastases and has not received systemic corticosteroid therapy in the 10 days prior to beginning study intervention * If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is: * Lenvatinib: 7 days * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent. OR * Uses contraception unless confirmed to be azoospermic * Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab or pembrolizumab/quavonlimab, or 30 days after the last dose of lenvatinib, whichever occurs last * Has adequate organ function * Female participants agree to abstain from breastfeeding during the study intervention period and for at least the time needed to eliminate study intervention after the last dose of study intervention. The length of time required for each study intervention is: * MK-1308A: 120 days * MK-3475: 120 days * Lenvatinib: 30 days Exclusion Criteria: * Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 10 days before the first dose of study intervention * Has current or history of known leptomeningeal involvement * Has received stereotactic or highly conformal radiotherapy within 2 weeks before the start of dosing * Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug * Has untreated or unresolved intracranial hemorrhage from central nervous system (CNS) metastasis * Has an active infection requiring systemic therapy * Has a known additional malignancy that is progressing or requires active treatment within the past 2 years * Has ocular melanoma * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has known history of immunodeficiency virus (HIV) * Has known history of hepatitis B or known hepatitis C virus * Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis * Has received prior systemic anticancer therapy within 4 weeks prior to randomization/allocation * Has a history of whole brain irradiation * Has received prior radiotherapy within 2 weeks of first dose of study intervention * Has had major surgery \<3 weeks prior to first dose of study intervention * Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention * Has had an allogeneic tissue/solid organ transplant

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • A.P.H. Paris, Hopital Saint Louis ( Site 4107)

    Paris, 75010, France

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865)

    Port Elizabeth, Eastern Cape, 6055, South Africa

  • CHU de Bordeaux- Hopital Saint Andre ( Site 4108)

    Bordeaux, Gironde, 33075, France

  • CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Calvary Mater Newcastle ( Site 4404)

    Waratah, New South Wales, 2298, Australia

  • Cape Town Oncology Trials ( Site 4864)

    Cape Town, Western Cape, 7570, South Africa

  • Centre Hospitalier Lyon Sud ( Site 4102)

    Pierre-Bénite, Rhone, 69495, France

  • Chaim Sheba Medical Center ( Site 4701)

    Ramat Gan, 5265601, Israel

  • Duke Cancer Institute ( Site 4005)

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)

    Milan, 20133, Italy

  • Gustave Roussy ( Site 4101)

    Villejuif, Île-de-France Region, 94805, France

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 4801)

    Barcelona, Catalonia, 08036, Spain

  • HaEmek Medical Center ( Site 4703)

    Afula, 1834111, Israel

  • Hadassah Ein Karem Jerusalem ( Site 4702)

    Jerusalem, 9112001, Israel

  • Hopital La Timone ( Site 4103)

    Marseille, Bouches-du-Rhone, 13005, France

  • Hospital Universitario Ramón y Cajal ( Site 4802)

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Inova Schar Cancer Institute ( Site 4011)

    Fairfax, Virginia, 22031, United States

  • Institut Claudius Regaud ( Site 4105)

    Toulouse, Haute-Garonne, 31059, France

  • Istituto Europeo di Oncologia ( Site 4301)

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 4355)

    Padova, 35128, Italy

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)

    Pretoria, Gauteng, 0181, South Africa

  • Martha Morehouse Tower ( Site 4020)

    Columbus, Ohio, 43221, United States

  • Melanoma Institute Australia ( Site 4402)

    Wollstonecraft, New South Wales, 2065, Australia

  • NYU Clinical Cancer Center ( Site 4002)

    New York, New York, 10016, United States

  • Policlinico Le Scotte - A.O. Senese ( Site 4377)

    Siena, 53100, Italy

  • Providence Saint John's Health Center ( Site 4010)

    Santa Monica, California, 90404, United States

  • Rabin Medical Center-Oncology ( Site 4705)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 4704)

    Haifa, 3109601, Israel

  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)

    Sandton, Gauteng, 2196, South Africa

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)

    Baltimore, Maryland, 21287, United States

  • The Angeles Clinic and Research Institute ( Site 4009)

    Los Angeles, California, 90025, United States

  • UCLA Hematology & Oncology ( Site 4004)

    Los Angeles, California, 90095, United States

  • Universitaetsspital Zuerich ( Site 4601)

    Zurich, 8058, Switzerland

  • University of Colorado, Anschutz Cancer Pavilion ( Site 4012)

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.