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
Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib; 7 days after lenvatinib is stopped, if participants are on pembrolizumab, pembrolizumab/quavonlimab, vibostolimab or a combination of the aforementioned drugs, no additional male contraception measures are needed
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, pembrolizumab/quavonlimab, vibostolimab, or 30 days after the last dose of lenvatinib, whichever occurs last
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 known history of hepatitis B
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

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 40 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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)
Baltimore Maryland, 21231, United States More Info
Study Coordinator
Contact
410-583-2970
NYU Clinical Cancer Center ( Site 2002)
New York New York, 10016, United States More Info
Study Coordinator
Contact
917-991-4174
Duke Cancer Institute ( Site 2005)
Durham North Carolina, 27710, United States More Info
Study Coordinator
Contact
919-660-9671
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 More Info
Study Coordinator
Contact
215-316-5151
West Cancer Center - East Campus ( Site 2014)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
Inova Schar Cancer Institute ( Site 2011)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-0631
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
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
Gustave Roussy ( Site 2101)
Villejuif Ile-de-France, 94800, 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
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
Istituto Oncologico Veneto IRCCS ( Site 2355)
Padova Veneto, 35128, Italy More Info
Study Coordinator
Contact
00390498215938
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
Policlinico Le Scotte - A.O. Senese ( Site 2377)
Siena , 53100, Italy More Info
Study Coordinator
Contact
+390577586335
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( 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
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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