Melanoma Clinical Trial

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

Summary

Substudy 02D 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 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has American Joint Committee on Cancer (AJCC) Stage IV, M1D melanoma
Is neurologically asymptomatic from brain metastases and has not received systemic corticosteroid therapy in the 10 days prior to beginning study intervention
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. The length of time required to continue contraception for each study intervention is:
Lenvatinib: 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
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 or pembrolizumab/quavonlimab, or 30 days after the last dose of lenvatinib, whichever occurs last
Has adequate organ function
Female participants agree to abstain from breastfeeding during the study intervention period and for at least the time needed to eliminate study intervention after the last dose of study intervention. The length of time required for each study intervention is:
MK-1308A: 120 days
MK-3475: 120 days
Lenvatinib: 30 days

Exclusion Criteria:

Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 10 days before the first dose of study intervention
Has current or history of known leptomeningeal involvement
Has received stereotactic or highly conformal radiotherapy within 2 weeks before the start of dosing
Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
Has untreated or unresolved intracranial hemorrhage from central nervous system (CNS) metastasis
Has an active infection requiring systemic therapy
Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
Has ocular melanoma
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has known history of immunodeficiency virus (HIV)
Has known history of hepatitis B or known hepatitis C virus
Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis
Has received prior systemic anticancer therapy within 4 weeks prior to randomization/allocation
Has a history of whole brain irradiation
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 or live attenuated vaccine within 30 days prior to the first dose of study intervention
Has had an allogeneic tissue/solid organ transplant

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

300

Study ID:

NCT04700072

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 36 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute ( Site 4009)
Los Angeles California, 90025, United States More Info
Study Coordinator
Contact
310-231-2121
UCLA Hematology & Oncology ( Site 4004)
Los Angeles California, 90095, United States More Info
Study Coordinator
Contact
310-794-6892
Providence Saint John's Health Center ( Site 4010)
Santa Monica California, 90404, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 4012)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-848-0442
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)
Baltimore Maryland, 21231, United States More Info
Study Coordinator
Contact
410-583-2970
NYU Clinical Cancer Center ( Site 4002)
New York New York, 10016, United States More Info
Study Coordinator
Contact
212-731-5431
Duke Cancer Institute ( Site 4005)
Durham North Carolina, 27710, United States More Info
Study Coordinator
Contact
919-660-9671
Martha Morehouse Tower ( Site 4020)
Columbus Ohio, 43221, United States More Info
Study Coordinator
Contact
614-293-4320
Inova Schar Cancer Institute ( Site 4011)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-0631
Calvary Mater Newcastle ( Site 4404)
Waratah New South Wales, 2298, Australia More Info
Study Coordinator
Contact
+61240143287
Melanoma Institute Australia ( Site 4402)
Wollstonecraft New South Wales, 2065, Australia
Hopital La Timone ( Site 4103)
Marseille Bouches-du-Rhone, 13005, France More Info
Study Coordinator
Contact
+33491388591
CHU de Bordeaux- Hopital Saint Andre ( Site 4108)
Bordeaux Gironde, 33075, France More Info
Study Coordinator
Contact
+33556794705
Institut Claudius Regaud ( Site 4105)
Toulouse cedex 9 Haute-Garonne, 31059, France More Info
Study Coordinator
Contact
+33531155101
Gustave Roussy ( Site 4101)
Villejuif Ile-de-France, 94800, France More Info
Study Coordinator
Contact
+33142114210
Centre Hospitalier Lyon Sud ( Site 4102)
Pierre Benite Rhone, 69495, France More Info
Study Coordinator
Contact
+33478861628
A.P.H. Paris, Hopital Saint Louis ( Site 4107)
Paris , 75010, France More Info
Study Coordinator
Contact
01 42 49 95 95
HaEmek Medical Center ( Site 4703)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+97246495723
Rambam Health Care Campus-Oncology ( Site 4704)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Hadassah Ein Karem Jerusalem ( Site 4702)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226776781
Rabin Medical Center-Oncology ( Site 4705)
Petah-Tikva , 49414, Israel More Info
Study Coordinator
Contact
+972-3-9378077
Chaim Sheba Medical Center ( Site 4701)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235304907
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)
Milano , 20133, Italy More Info
Study Coordinator
Contact
+390223902557
Istituto Europeo di Oncologia ( Site 4301)
Milano , 20141, Italy More Info
Study Coordinator
Contact
+390105600384
Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)
Napoli , 80131, Italy More Info
Study Coordinator
Contact
+390815903431
Istituto Oncologico Veneto IRCCS ( Site 4355)
Padova , 35128, Italy More Info
Study Coordinator
Contact
+390498215938
Policlinico Le Scotte - A.O. Senese ( Site 4377)
Siena , 53100, Italy More Info
Study Coordinator
Contact
00390577586335
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865)
Port Elizabeth Eastern Cape, 6055, South Africa More Info
Study Coordinator
Contact
+27413630581
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)
Pretoria Gauteng, 0181, South Africa More Info
Study Coordinator
Contact
+27123466701
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)
Sandton Gauteng, 2196, South Africa More Info
Study Coordinator
Contact
+27118830900
Cape Town Oncology Trials ( Site 4864)
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 4802)
Madrid Madrid, Comunidad De, 28034, Spain More Info
Study Coordinator
Contact
+34913368263
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)
Genève Geneve, 1211, Switzerland More Info
Study Coordinator
Contact
+41223729862
CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)
Lausanne Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 4601)
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:

300

Study ID:

NCT04700072

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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