Melanoma Clinical Trial

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

Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

315

Study ID:

NCT04305054

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 57 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute ( Site 2009)
Los Angeles California, 90025, United States More Info
Study Coordinator
Contact
310-231-2121
UCLA Hematology & Oncology ( Site 2004)
Los Angeles California, 90095, United States More Info
Study Coordinator
Contact
310-794-6892
Providence Saint John's Health Center ( Site 2010)
Santa Monica California, 90404, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 2012)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-848-0442
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026
Gainesville Florida, 32610, United States More Info
Study Coordinator
Contact
843-340-0085
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)
Baltimore Maryland, 21287, United States More Info
Study Coordinator
Contact
410-583-2970
NYU Clinical Cancer Center ( Site 2002)
New York New York, 10016, United States
Duke Cancer Institute ( Site 2005)
Durham North Carolina, 27710, United States
Martha Morehouse Tower ( Site 2020)
Columbus Ohio, 43221, United States More Info
Study Coordinator
Contact
614-293-4320
Oregon Health & Science University ( Site 2013)
Portland Oregon, 97239, United States
University of Pennsylvania Abramson Cancer Center ( Site 2008)
Philadelphia Pennsylvania, 19104, United States
West Cancer Center - East Campus ( Site 2014)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
Mays Cancer Center ( Site 2025)
San Antonio Texas, 78229, United States More Info
Study Coordinator
Contact
210-450-5798
Inova Schar Cancer Institute ( Site 2011)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-0631
Sanatorio Finochietto ( Site 2245)
Buenos Aires , C1187, Argentina More Info
Study Coordinator
Contact
5491158216233
Calvary Mater Newcastle-Medical Oncology ( Site 2404)
Waratah New South Wales, 2298, Australia More Info
Study Coordinator
Contact
+61249211561
Melanoma Institute Australia ( Site 2402)
Wollstonecraft New South Wales, 2065, Australia More Info
Study Coordinator
Contact
+61299117321
Tasman Oncology Research Pty Ltd ( Site 2403)
Southport Queensland, 4120, Australia More Info
Study Coordinator
Contact
+61 7 5613 2480
Fiona Stanley Hospital ( Site 2401)
Murdoch Western Australia, 6150, Australia More Info
Study Coordinator
Contact
+61861522222
CIDO SpA-Oncology ( Site 2256)
Temuco Araucania, 48102, Chile More Info
Study Coordinator
Contact
569 5 798 31 73
IC La Serena Research ( Site 2254)
La Serena Coquimbo, 17204, Chile More Info
Study Coordinator
Contact
56953360057
FALP-UIDO ( Site 2251)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56224457254
Oncovida ( Site 2257)
Santiago Region M. De Santiago, 75100, Chile More Info
Study Coordinator
Contact
5624205100
Bradfordhill ( Site 2252)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2261)
Bogota Distrito Capital De Bogota, 11132, Colombia More Info
Study Coordinator
Contact
573103469453
Fundación Valle del Lili ( Site 2265)
Cali Valle Del Cauca, 76003, Colombia More Info
Study Coordinator
Contact
6023319090
Hopital La Timone ( Site 2103)
Marseille Bouches-du-Rhone, 13005, France More Info
Study Coordinator
Contact
+33491388591
CHU de Bordeaux- Hopital Saint Andre ( Site 2108)
Bordeaux Gironde, 33075, France More Info
Study Coordinator
Contact
+33556794705
Institut Claudius Regaud ( Site 2105)
Toulouse cedex 9 Haute-Garonne, 31059, France More Info
Study Coordinator
Contact
33531155675
Gustave Roussy ( Site 2101)
Villejuif Ile-de-France, 94805, France More Info
Study Coordinator
Contact
+33142114210
C.H. Lyon Sud ( Site 2102)
Pierre Benite Rhone, 69495, France More Info
Study Coordinator
Contact
+33478861628
A.P.H. Paris, Hopital Saint Louis ( Site 2107)
Paris , 75010, France More Info
Study Coordinator
Contact
+33142499595
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 2212)
Athens Attiki, 115 2, Greece More Info
Study Coordinator
Contact
00306944681159
European Interbalkan Medical Center-Oncology Department ( Site 2211)
Thessaloniki , 57001, Greece More Info
Study Coordinator
Contact
306942608228
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221)
Szeged Csongrad, 6720, Hungary More Info
Study Coordinator
Contact
+36704399976
HaEmek Medical Center ( Site 2703)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+97246495723
Rambam Health Care Campus-Oncology ( Site 2704)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Hadassah Ein Karem Jerusalem ( Site 2702)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226776781
Rabin Medical Center-Oncology ( Site 2705)
Petah-Tikva , 49414, Israel More Info
Study Coordinator
Contact
+972-3-9378077
Chaim Sheba Medical Center ( Site 2701)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235304907
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)
Milano , 20133, Italy More Info
Study Coordinator
Contact
+390223902557
Istituto Europeo di Oncologia ( Site 2301)
Milano , 20141, Italy More Info
Study Coordinator
Contact
+390294372158
Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)
Napoli , 80131, Italy More Info
Study Coordinator
Contact
+390815903431
Istituto Oncologico Veneto IRCCS ( Site 2355)
Padova , 35128, Italy More Info
Study Coordinator
Contact
00390498215938
Policlinico Le Scotte - A.O. Senese ( Site 2377)
Siena , 53100, Italy More Info
Study Coordinator
Contact
+390577586335
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
48225462031
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231)
Gdansk Pomorskie, 80-95, Poland More Info
Study Coordinator
Contact
48585844571
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865)
Port Elizabeth Eastern Cape, 6055, South Africa More Info
Study Coordinator
Contact
+27413630581
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)
Pretoria Gauteng, 0181, South Africa More Info
Study Coordinator
Contact
+27123466701
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863)
Sandton Gauteng, 2196, South Africa More Info
Study Coordinator
Contact
+27118830900
Steve Biko Academic Hospital-Medical Oncology ( Site 2862)
Tshwane Gauteng, 0002, South Africa More Info
Study Coordinator
Contact
+27123541771
Cape Town Oncology Trials ( Site 2864)
Cape Town Western Cape, 7570, South Africa More Info
Study Coordinator
Contact
27219443832
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona Cataluna, 08036, Spain More Info
Study Coordinator
Contact
+34932275402
Hospital Universitario Ramón y Cajal ( Site 2802)
Madrid Madrid, Comunidad De, 28034, Spain More Info
Study Coordinator
Contact
+34913368263
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603)
Genève Geneve, 1211, Switzerland More Info
Study Coordinator
Contact
+41223729862
CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)
Lausanne Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 2601)
Zuerich Flughafen Zurich, 8058, Switzerland More Info
Study Coordinator
Contact
+41442552588

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

315

Study ID:

NCT04305054

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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