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New hope for melanoma: drug combos show promise in major trial

NCT ID NCT04305054

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding other treatments to the drug pembrolizumab can help people with advanced melanoma that hasn't been treated before. Researchers checked safety and how many people's tumors shrank or disappeared. The trial involved 335 participants and was part of a larger research platform.

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

335 people

The number who actually took part.

Started

Jul 2020

Finished

May 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 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 histologically or cytologically confirmed melanoma * Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy * Has been untreated for advanced disease. * Has provided a tumor biopsy * 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 (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 * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: * Is not a WOCBP OR * Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) 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: * MK-4280A: 120 days * MK-1308A: 120 days * MK-7684: 50 days * MK-3475: 120 days * Lenvatinib: 30 days * ATRA: 30 days * Has adequate organ function * Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy) Exclusion Criteria: * Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention * Has a known additional malignancy that is progressing or requires active treatment within the past 2 years * Has known central nervous system (CNS) metastases and/or carcinomatous meningitis * Has ocular or mucosal melanoma * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has an active infection requiring systemic therapy * Has known history of human immunodeficiency virus (HIV) * Has history of Hepatitis B or known Hepatitis C virus infection * Has a history of (noninfectious) pneumonitis * Has a history of active tuberculosis (TB) * Has received prior systemic anticancer therapy within 4 weeks prior to randomization * 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 vaccine within 30 days before the first dose of study intervention * Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention * Has had an allogeneic tissue/solid organ transplant * Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study * Participants who receive lenvatinib have the following additional exclusion criteria: * Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula * Has radiographic evidence of encasement of invasion of a major blood vessel, or of intratumoral cavitation * Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention * Has clinically significant cardiovascular disease within 12 months from first dose of study intervention * Has urine protein ≥1 g/24-hour. * Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 melanoma type 1 diabetes mellitus 12

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 2107)

    Paris, 75010, France

  • Bradfordhill ( Site 2252)

    Santiago, Region M. de Santiago, 8420383, Chile

  • C.H. Lyon Sud ( Site 2102)

    Pierre-Bénite, Rhone, 69495, France

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865)

    Port Elizabeth, Eastern Cape, 6055, South Africa

  • CHU de Bordeaux- Hopital Saint Andre ( Site 2108)

    Bordeaux, Gironde, 33075, France

  • CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • CIDO SpA-Oncology ( Site 2256)

    Temuco, Araucania, 4810218, Chile

  • Calvary Mater Newcastle-Medical Oncology ( Site 2404)

    Waratah, New South Wales, 2298, Australia

  • Cape Town Oncology Trials ( Site 2864)

    Cape Town, Western Cape, 7570, South Africa

  • Chaim Sheba Medical Center ( Site 2701)

    Ramat Gan, 5265601, Israel

  • Clinica Adventista Belgrano-Oncology ( Site 2242)

    Caba., Buenos Aires, C1430EGF, Argentina

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2261)

    Bogotá, Bogota D.C., 111321, Colombia

  • Duke Cancer Institute ( Site 2005)

    Durham, North Carolina, 27710, United States

  • European Interbalkan Medical Center-Oncology Department ( Site 2211)

    Thessaloniki, 570 01, Greece

  • FALP-UIDO ( Site 2251)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fiona Stanley Hospital ( Site 2401)

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)

    Milan, 20133, Italy

  • Fundación Valle del Lili ( Site 2265)

    Cali, Valle del Cauca Department, 760032, Colombia

  • General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 2212)

    Athens, Attica, 115 26, Greece

  • Gustave Roussy ( Site 2101)

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

  • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2801)

    Barcelona, Catalonia, 08036, Spain

  • HaEmek Medical Center ( Site 2703)

    Afula, 1834111, Israel

  • Hadassah Ein Karem Jerusalem ( Site 2702)

    Jerusalem, 9112001, Israel

  • Hopital La Timone ( Site 2103)

    Marseille, Bouches-du-Rhone, 13005, France

  • Hospital Universitario Ramón y Cajal ( Site 2802)

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603)

    Geneva, Canton of Geneva, 1211, Switzerland

  • IC La Serena Research ( Site 2254)

    La Serena, Coquimbo Region, 1720430, Chile

  • Inova Schar Cancer Institute ( Site 2011)

    Fairfax, Virginia, 22031, United States

  • Institut Claudius Regaud ( Site 2105)

    Toulouse, Haute-Garonne, 31059, France

  • Instituto Alexander Fleming-Alexander Fleming ( Site 2243)

    Buenos Aires, Buenos Aires F.D., 1426ANZ, Argentina

  • Istituto Europeo di Oncologia ( Site 2301)

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 2355)

    Padova, 35128, Italy

  • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)

    Pretoria, Gauteng, 0181, South Africa

  • Martha Morehouse Tower ( Site 2020)

    Columbus, Ohio, 43221, United States

  • Mays Cancer Center ( Site 2025)

    San Antonio, Texas, 78229, United States

  • Melanoma Institute Australia ( Site 2402)

    Wollstonecraft, New South Wales, 2065, Australia

  • NYU Clinical Cancer Center ( Site 2002)

    New York, New York, 10016, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2233)

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Oncovida ( Site 2257)

    Santiago, Region M. de Santiago, 7500994, Chile

  • Oregon Health & Science University ( Site 2013)

    Portland, Oregon, 97239, United States

  • Policlinico Le Scotte - A.O. Senese ( Site 2377)

    Siena, 53100, Italy

  • Providence Saint John's Health Center ( Site 2010)

    Santa Monica, California, 90404, United States

  • R.J. Zuckerberg Cancer Center ( Site 2032)

    Lake Success, New York, 11042, United States

  • Rabin Medical Center-Oncology ( Site 2705)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 2704)

    Haifa, 3109601, Israel

  • Sanatorio Finochietto ( Site 2245)

    Buenos Aires, C1187AAN, Argentina

  • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863)

    Sandton, Gauteng, 2196, South Africa

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)

    Baltimore, Maryland, 21287, United States

  • Steve Biko Academic Hospital-Medical Oncology ( Site 2862)

    Pretoria, Gauteng, 0002, South Africa

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221)

    Szeged, Csongrád megye, 6720, Hungary

  • Tasman Oncology Research Pty Ltd ( Site 2403)

    Southport, Queensland, 4120, Australia

  • The Angeles Clinic and Research Institute ( Site 2009)

    Los Angeles, California, 90025, United States

  • UCLA Hematology & Oncology ( Site 2004)

    Los Angeles, California, 90095, United States

  • Universitaetsspital Zuerich ( Site 2601)

    Zuerich Flughafen, Canton of Zurich, 8058, Switzerland

  • University of Colorado, Anschutz Cancer Pavilion ( Site 2012)

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026)

    Gainesville, Florida, 32608, United States

  • University of Pennsylvania Abramson Cancer Center ( Site 2008)

    Philadelphia, Pennsylvania, 19104, United States

  • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231)

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • West Cancer Center - East Campus ( Site 2014)

    Germantown, Tennessee, 38138, United States

More trials for these conditions

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