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ACTIVE NOT RECRUITING

NCT04305054

PHASE1/PHASE2

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment

Official title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2020-07-01

Completion Date

2026-05-20

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Melanoma

Interventions

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Vibostolimab

Administered via IV infusion at a specified dose on specified days

BIOLOGICAL

Pembrolizumab/Quavonlimab

Administered via IV infusion at a specified dose on specified days

DRUG

Lenvatinib

Administered via oral capsule at a specified dose on specified days

BIOLOGICAL

Favezelimab/Pembrolizumab

Administered via IV infusion at a specified dose on specified days

DRUG

ATRA

Administered via oral capsule at a specified dose on specified days

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

Locations (60)

The Angeles Clinic and Research Institute ( Site 2009)

Los Angeles, California, United States

UCLA Hematology & Oncology ( Site 2004)

Los Angeles, California, United States

Providence Saint John's Health Center ( Site 2010)

Santa Monica, California, United States

University of Colorado, Anschutz Cancer Pavilion ( Site 2012)

Aurora, Colorado, United States

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

Gainesville, Florida, United States

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

Baltimore, Maryland, United States

R.J. Zuckerberg Cancer Center ( Site 2032)

Lake Success, New York, United States

NYU Clinical Cancer Center ( Site 2002)

New York, New York, United States

Duke Cancer Institute ( Site 2005)

Durham, North Carolina, United States

Martha Morehouse Tower ( Site 2020)

Columbus, Ohio, United States

Oregon Health & Science University ( Site 2013)

Portland, Oregon, United States

University of Pennsylvania Abramson Cancer Center ( Site 2008)

Philadelphia, Pennsylvania, United States

West Cancer Center - East Campus ( Site 2014)

Germantown, Tennessee, United States

Mays Cancer Center ( Site 2025)

San Antonio, Texas, United States

Inova Schar Cancer Institute ( Site 2011)

Fairfax, Virginia, United States

Clinica Adventista Belgrano-Oncology ( Site 2242)

Caba., Buenos Aires, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 2243)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Finochietto ( Site 2245)

Buenos Aires, Argentina

Calvary Mater Newcastle-Medical Oncology ( Site 2404)

Waratah, New South Wales, Australia

Melanoma Institute Australia ( Site 2402)

Wollstonecraft, New South Wales, Australia

Tasman Oncology Research Pty Ltd ( Site 2403)

Southport, Queensland, Australia

Fiona Stanley Hospital ( Site 2401)

Murdoch, Western Australia, Australia

IC La Serena Research ( Site 2254)

La Serena, Coquimbo Region, Chile

FALP-UIDO ( Site 2251)

Santiago, Region M. de Santiago, Chile

Oncovida ( Site 2257)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 2252)

Santiago, Region M. de Santiago, Chile

CIDO SpA-Oncology ( Site 2256)

Temuco, Región de la Araucanía, Chile

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

Bogotá, Bogota D.C., Colombia

Fundación Valle del Lili ( Site 2265)

Cali, Valle del Cauca Department, Colombia

Hopital La Timone ( Site 2103)

Marseille, Bouches-du-Rhone, France

CHU de Bordeaux- Hopital Saint Andre ( Site 2108)

Bordeaux, Gironde, France

Institut Claudius Regaud ( Site 2105)

Toulouse, Haute-Garonne, France

C.H. Lyon Sud ( Site 2102)

Pierre-Bénite, Rhone, France

A.P.H. Paris, Hopital Saint Louis ( Site 2107)

Paris, France

Gustave Roussy ( Site 2101)

Villejuif, Île-de-France Region, France

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

Athens, Attica, Greece

European Interbalkan Medical Center-Oncology Department ( Site 2211)

Thessaloniki, Greece

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

Szeged, Csongrád megye, Hungary

HaEmek Medical Center ( Site 2703)

Afula, Israel

Rambam Health Care Campus-Oncology ( Site 2704)

Haifa, Israel

Hadassah Ein Karem Jerusalem ( Site 2702)

Jerusalem, Israel

Rabin Medical Center-Oncology ( Site 2705)

Petah Tikva, Israel

Chaim Sheba Medical Center ( Site 2701)

Ramat Gan, Israel

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

Milan, Italy

Istituto Europeo di Oncologia ( Site 2301)

Milan, Italy

Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)

Naples, Italy

Istituto Oncologico Veneto IRCCS ( Site 2355)

Padova, Italy

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

Siena, Italy

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

Warsaw, Masovian Voivodeship, Poland

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

Gdansk, Pomeranian Voivodeship, Poland

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865)

Port Elizabeth, Eastern Cape, South Africa

Steve Biko Academic Hospital-Medical Oncology ( Site 2862)

Pretoria, Gauteng, South Africa

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)

Pretoria, Gauteng, South Africa

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

Sandton, Gauteng, South Africa

Cape Town Oncology Trials ( Site 2864)

Cape Town, Western Cape, South Africa

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

Barcelona, Catalonia, Spain

Hospital Universitario Ramón y Cajal ( Site 2802)

Madrid, Madrid, Comunidad de, Spain

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

Geneva, Canton of Geneva, Switzerland

CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)

Lausanne, Canton of Vaud, Switzerland

Universitaetsspital Zuerich ( Site 2601)

Zuerich Flughafen, Canton of Zurich, Switzerland

Clinical Research Directory

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (60)