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Double-Drug attack shows promise against advanced melanoma

NCT ID NCT03820986

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 lenvatinib to pembrolizumab works better than pembrolizumab alone for people with advanced melanoma that hasn't been treated yet. About 674 adults with stage III or IV melanoma took part. The goal was to see if the combination helps people live longer or keeps the cancer from growing longer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

674 people

The number who actually took part.

Started

Mar 2019

Finished

Nov 2024

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: * Has histologically or cytologically confirmed melanoma. * Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy. * Has been untreated for advanced or metastatic disease except as follows: 1. Proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. Participants that do not have a BRAF V600 mutation but did receive BRAF or BRAF/mitogen-activated extracellular signal-regulated kinase 1/2 Inhibitor (MEKi) therapy are eligible to participate in this study after discussion with the medical monitor. 2. Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], anti-programmed cell death 1 \[anti-PD-1\] therapy or interferon) will only be permitted if relapse did not occur during active treatment or within 6 months of treatment discontinuation. * Have documentation of BRAF V600-activating mutation status or consent to BRAF V600 mutation testing during the Screening period (participants with BRAF mutation-positive melanoma as well as BRAF wild-type or unknown are eligible). * Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1. * Provides a tumor biopsy. Participants must submit tumor sample during Screening for confirmation of adequacy of tumor tissue at a central pathology laboratory. Participants who do not submit a tumor tissue sample will not be randomized. The tumor biopsy may not be obtained from a lone target lesion. Confirmation of presence of tumor tissue is not required prior to randomization. * Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications from the intervention. * Male participants must agree to use contraception during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period. Please note that 7 days after lenvatinib/placebo is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed. Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. * Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP). OR 2. A WOCBP who agrees to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment. * The participant (or legally acceptable representative) has provided documented informed consent for the study. * Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1. * Has adequate organ function. Exclusion Criteria: * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1, non-ulcerated primary melanoma \<1 mm in depth with no nodal involvement) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has ocular melanoma. * Has known hypersensitivity to active substances or any of their excipients including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody. * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has an active infection requiring systemic therapy. * Has known history of human immunodeficiency virus (HIV) infection * Has known history of or is positive for hepatitis B virus or hepatitis C virus infection. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has a history of active tuberculosis (Bacillus tuberculosis). * Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. * Has had a major surgery within 3 weeks prior to first dose of study intervention. Note: Adequate wound healing after major surgery must be assessed clinically independent of time elapsed for eligibility. * Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula. * Has radiographic evidence of encasement or invasion of major blood vessel, or of intratumoral cavitation. * Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study treatment. * Has clinically significant cardiovascular disease from 12 months of the first dose of study treatment including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Has urine protein ≥1 g/24-hour. Note: Participants with ≥2+ (≥100 mg/dL) proteinuria on urine dipstick testing (or urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria. * Prolongation of QTcF interval to \>480 ms. Note: If the QTcF is prolonged to \>480 ms in the presence of a pacemaker, contact the Sponsor to determine eligibility. * Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram. * Has received prior therapy in the adjuvant setting. Note: Targeted therapy, anti-CTLA-4, or anti-PD-1 may be allowed. * Has received prior systemic treatment for unresectable or metastatic melanoma other than targeted therapy as noted in Inclusion Criteria above * Has received prior therapy with a monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study treatment or not recovered (≤Grade 1 or at Baseline) from adverse events due to previously administered agents. Exception to this rule would be use of denosumab, which is not excluded. Note: Participants with alopecia and ≤Grade 2 neuropathy are an exception and may enroll. * Has received prior radiotherapy within 2 weeks of first dose of study treatment (Cycle 1 Day 1). Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Has received live vaccine within 30 days before the first dose of study treatment. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Has had an allogeneic tissue/solid organ transplant. * Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.

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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.

Malignant melanoma

Contacts and locations

Locations

  • AMG Oncology ( Site 0714)

    Park Ridge, Illinois, 60068, United States

  • ASST Papa Giovanni XXIII ( Site 0062)

    Bergamo, Abruzzo, 24127, Italy

  • Akademiska Sjukhuset ( Site 0218)

    Uppsala, Uppsala County, 751 85, Sweden

  • Atlantic Health System ( Site 0768)

    Morristown, New Jersey, 07960, United States

  • Azienda Ospedaliera Universitaria Senese ( Site 0065)

    Siena, Tuscany, 53100, Italy

  • BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661)

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Baptist MD Anderson Cancer Center ( Site 0767)

    Jacksonville, Florida, 32207, United States

  • Beijing Cancer Hospital ( Site 0601)

    Beijing, Beijing Municipality, 100036, China

  • CHRU Lille - Hopital Claude Huriez ( Site 0004)

    Lille, Nord, 59037, France

  • CHU Dijon Bourgogne ( Site 0010)

    Dijon, Cote-d Or, 21079, France

  • CHU de Rouen ( Site 0013)

    Rouen, Seine-Maritime, 76000, France

  • CHU de la Miletrie Poitiers ( Site 0011)

    Poitiers, Vienne, 86021, France

  • California Pacific Medical Center Research Institute ( Site 0705)

    San Francisco, California, 94115, United States

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 0805)

    Port Elizabeth, Eastern Cape, 6045, South Africa

  • Cape Town Oncology Trials Pty Ltd ( Site 0803)

    Kraaifontein, Western Cape, 7570, South Africa

  • Centrallasarettet Vaxjo ( Site 0214)

    Vaxjo, Kronoberg County, 351 85, Sweden

  • Centre Hospitalier Victor Dupouy ( Site 0012)

    Argenteuil, Val-d Oise, 95100, France

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)

    Montreal, Quebec, H2W 3E4, Canada

  • Centro Investigación del Cáncer James Lind ( Site 0425)

    Temuco, Araucania, 4780000, Chile

  • Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Chaim Sheba Medical Center ( Site 0304)

    Ramat Gan, 5262000, Israel

  • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182)

    A Coruña, La Coruna, 15006, Spain

  • Derriford Hospital ( Site 0129)

    Plymouth, PL6 8DH, United Kingdom

  • Eastern Health ( Site 0457)

    Box Hill, Victoria, 3128, Australia

  • Fiona Stanley Hospital ( Site 0456)

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064)

    Milan, 20133, Italy

  • Fudan University Shanghai Cancer Center ( Site 0607)

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Provincial Cancer Hospital ( Site 0612)

    Fuzhou, Fujian, 350014, China

  • Fundacion Arturo Lopez Perez FALP ( Site 0421)

    Santiago, Region M. de Santiago, 7500921, Chile

  • Guys and St Thomas NHS Foundation Trust ( Site 0126)

    London, London, City of, SE1 9RT, United Kingdom

  • HaEmek Medical Center ( Site 0306)

    Afula, 1834111, Israel

  • Hadassah Ein Karem Hebrew University Medical Center ( Site 0305)

    Jerusalem, 9112001, Israel

  • Hautkrebszentrum Buxtehude ( Site 0037)

    Buxtehude, Lower Saxony, 21614, Germany

  • Henan Cancer Hospital ( Site 0610)

    Zhengzhou, Henan, 450003, China

  • Hopital ARCHET 2 ( Site 0009)

    Nice, Alpes-Maritimes, 06200, France

  • Hopital Ambroise Pare Boulogne ( Site 0007)

    Boulogne-Billancourt, Hauts-de-Seine, 92100, France

  • Hopital La Timone ( Site 0002)

    Marseille, Bouches-du-Rhone, 13385, France

  • Hospital Clinic i Provincial Barcelona ( Site 0190)

    Barcelona, 08036, Spain

  • Hospital Duran i Reinals ICO de Hospitalet ( Site 0187)

    Hospitalet Del Llobregat, Barcelona, 08908, Spain

  • Hospital General Universitario Gregorio Maranon ( Site 0191)

    Madrid, 28009, Spain

  • Hospital Sao Vicente de Paulo ( Site 0396)

    Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

  • Hospital Universitario Carlos Haya ( Site 0186)

    Málaga, 29010, Spain

  • Hospital Universitario Insular de Gran Canaria ( Site 0189)

    Las Palmas de Gran Canaria, Las Palmas, 35001, Spain

  • Hospital Universitario La Paz ( Site 0184)

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla ( Site 0181)

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramon y Cajal ( Site 0183)

    Madrid, 28034, Spain

  • Hospital de Caridade de Ijui ( Site 0391)

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Illinois Cancer Care, PC ( Site 0765)

    Peoria, Illinois, 61615, United States

  • Inova Schar Cancer Institute ( Site 0739)

    Fairfax, Virginia, 22031-4867, United States

  • Institut Claudius Regaud IUCT Oncopole ( Site 0003)

    Toulouse, Haute-Garonne, 31059, France

  • Institut Gustave Roussy ( Site 0001)

    Villejuif, Val-de-Marne, 94805, France

  • Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394)

    Rio de Janeiro, 20220-410, Brazil

  • Istituto Europeo di Oncologia ( Site 0067)

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 0061)

    Naples, 80131, Italy

  • Istituto Oncologico Veneto ( Site 0063)

    Padova, 35128, Italy

  • John Wayne Cancer Institute ( Site 0706)

    Santa Monica, California, 90404, United States

  • Kantonsspital Graubuenden ( Site 0091)

    Chur, Kanton Graubünden, 7000, Switzerland

  • Kantonsspital Winterthur ( Site 0095)

    Winterthur, Canton of Zurich, 8401, Switzerland

  • Karolinska Universitetssjukhuset ( Site 0211)

    Solna, Stockholm County, 171 64, Sweden

  • Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035)

    Hannover, Baden-Wurttemberg, 30625, Germany

  • Kyungpook National University Chilgok Hospital ( Site 0553)

    Daegu, Taegu-Kwangyokshi, 41404, South Korea

  • LKH Universitatsklinikum Graz ( Site 0776)

    Graz, Styria, 8036, Austria

  • Laenssjukhuset Ryhov ( Site 0215)

    Jönköping, Jönköping County, 551 85, Sweden

  • Lions Gate Hospital ( Site 0662)

    North Vancouver, British Columbia, V7L 2L7, Canada

  • Lismore Base Hospital ( Site 0453)

    Lismore, Australian Capital Territory, 2480, Australia

  • McGill University Health Centre ( Site 0651)

    Montreal, Quebec, H4A 3J1, Canada

  • Medizinische Universitat Wien ( Site 0778)

    Vienna, 1090, Austria

  • Melanoma Institute Australia ( Site 0452)

    North Sydney, New South Wales, 2060, Australia

  • Mid-Florida Cancer Centers ( Site 0764)

    Orange City, Florida, 32763, United States

  • Minnesota Oncology Specialist, PA ( Site 0766)

    Fridley, Minnesota, 55432, United States

  • Nanjing Drum Tower Hospital ( Site 0609)

    Nanjing, Jiangsu, 210008, China

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278)

    Gliwice, Silesian Voivodeship, 44-102, Poland

  • Norrlands Universitetssjukhus ( Site 0216)

    Umeå, Västerbotten County, 901 85, Sweden

  • OHSU Center for Health & Healing ( Site 0731)

    Portland, Oregon, 97239, United States

  • Oncocentro ( Site 0424)

    Viña del Mar, Valparaiso, 2520598, Chile

  • PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399)

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Pontificia Universidad Catolica de Chile ( Site 0422)

    Santiago, Region M. de Santiago, 8330024, Chile

  • Pratia MCM Krakow ( Site 0280)

    Krakow, Lesser Poland Voivodeship, 30-510, Poland

  • Princess Alexandra Hospital ( Site 0454)

    Wooloongabba, Queensland, 4102, Australia

  • Rabin Medical Center ( Site 0302)

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center ( Site 0301)

    Haifa, 3109601, Israel

  • SRH Wald-Klinikum Gera GmbH ( Site 0042)

    Gera, Thuringia, 07548, Germany

  • Sahlgrenska Universitetssjukhuset ( Site 0212)

    Gothenburg, Västra Götaland County, 413 45, Sweden

  • Samsung Medical Center ( Site 0551)

    Seoul, 06351, South Korea

  • Sandton Oncology Medical Group PTY LTD ( Site 0802)

    Johannesburg, Gauteng, 2196, South Africa

  • Seoul National University Hospital ( Site 0554)

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System ( Site 0552)

    Seoul, 03722, South Korea

  • Shamir Medical Center-Assaf Harofeh ( Site 0308)

    Ẕerifin, 70300, Israel

  • Singleton Hospital ( Site 0131)

    Swansea, SA2 8QA, United Kingdom

  • Sir Run Run Shaw Hospital ( Site 0605)

    Hangzhou, Zhejiang, 310018, China

  • Skanes Universitetssjukhus ( Site 0213)

    Lund, Skåne County, 221 85, Sweden

  • Sociedad Medica Aren y Bachero Limitada ( Site 0426)

    Santiago, Region M. de Santiago, 8420383, Chile

  • Soroka Medical Center ( Site 0303)

    Beersheba, 8457108, Israel

  • Sourasky Medical Center ( Site 0307)

    Tel Aviv, 6423906, Israel

  • St. Vincent Frontier Cancer Center ( Site 0724)

    Billings, Montana, 59102, United States

  • Sun Yat-Sen University Cancer Center ( Site 0602)

    Guangzhou, Guangdong, 510000, China

  • Sunnybrook Research Institute ( Site 0654)

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272)

    Poznan, Greater Poland Voivodeship, 60-780, Poland

  • The Angeles Clinic and Research Institute ( Site 0707)

    Los Angeles, California, 90025, United States

  • The First Hospital Of Jilin University ( Site 0603)

    Changchun, Jilin, 130021, China

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0606)

    Tianjin, Tianjin Municipality, 300060, China

  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704)

    San Francisco, California, 30322, United States

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397)

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Universitaetsklinikum Carl Gustav Carus ( Site 0041)

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Erlangen ( Site 0044)

    Erlangen, Bavaria, 91054, Germany

  • Universitaetsklinikum Leipzig ( Site 0040)

    Leipzig, Saxony, 04103, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033)

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036)

    Würzburg, Bavaria, 97080, Germany

  • Universitaetsspital Basel ( Site 0094)

    Basel, Canton of Basel-City, 4031, Switzerland

  • Universitaetsspital Zuerich ( Site 0092)

    Zuerich-Flughafen, Canton of Zurich, 8058, Switzerland

  • University of Colorado Cancer Center ( Site 0708)

    Aurora, Colorado, 80045, United States

  • University of North Carolina - Cancer Hospital ( Site 0751)

    Chapel Hill, North Carolina, 27514, United States

  • Uniwersyteckie Centrum Kliniczne ( Site 0281)

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Valley Hospital ( Site 0749)

    Paramus, New Jersey, 07652, United States

  • Western General Hospital ( Site 0121)

    Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

  • Westmead Hospital ( Site 0451)

    Westmead, New South Wales, 2145, Australia

  • Yale Cancer Center ( Site 0709)

    New Haven, Connecticut, 06510, United States

  • Yunnan Cancer Hospital ( Site 0604)

    Kunming, Yunnan, 430030, China

  • Zhejiang Cancer Hospital ( Site 0608)

    Hangzhou, Zhejiang, 310022, China

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