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:

Active, not 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
UCLA Hematology & Oncology ( Site 4004)
Los Angeles California, 90095, United States
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)
Baltimore Maryland, 21287, United States
NYU Clinical Cancer Center ( Site 4002)
New York New York, 10016, United States
Duke Cancer Institute ( Site 4005)
Durham North Carolina, 27710, United States
Martha Morehouse Tower ( Site 4020)
Columbus Ohio, 43221, United States
Inova Schar Cancer Institute ( Site 4011)
Fairfax Virginia, 22031, United States
Calvary Mater Newcastle ( Site 4404)
Waratah New South Wales, 2298, Australia
Melanoma Institute Australia ( Site 4402)
Wollstonecraft New South Wales, 2065, Australia
Hopital La Timone ( Site 4103)
Marseille Bouches-du-Rhone, 13005, France
CHU de Bordeaux- Hopital Saint Andre ( Site 4108)
Bordeaux Gironde, 33075, France
Institut Claudius Regaud ( Site 4105)
Toulouse cedex 9 Haute-Garonne, 31059, France
Gustave Roussy ( Site 4101)
Villejuif Ile-de-France, 94800, France
Centre Hospitalier Lyon Sud ( Site 4102)
Pierre Benite Rhone, 69495, France
A.P.H. Paris, Hopital Saint Louis ( Site 4107)
Paris , 75010, France
HaEmek Medical Center ( Site 4703)
Afula , 18341, Israel
Rambam Health Care Campus-Oncology ( Site 4704)
Haifa , 31096, Israel
Hadassah Ein Karem Jerusalem ( Site 4702)
Jerusalem , 91120, Israel
Rabin Medical Center-Oncology ( Site 4705)
Petah-Tikva , 49414, Israel
Chaim Sheba Medical Center ( Site 4701)
Ramat Gan , 52656, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)
Milano , 20133, Italy
Istituto Europeo di Oncologia ( Site 4301)
Milano , 20141, Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)
Napoli , 80131, Italy
Istituto Oncologico Veneto IRCCS ( Site 4355)
Padova , 35128, Italy
Policlinico Le Scotte - A.O. Senese ( Site 4377)
Siena , 53100, Italy
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865)
Port Elizabeth Eastern Cape, 6055, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)
Pretoria Gauteng, 0181, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)
Sandton Gauteng, 2196, South Africa
Cape Town Oncology Trials ( Site 4864)
Cape Town Western Cape, 7570, South Africa
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
Barcelona Cataluna, 08036, Spain
Hospital Universitario Ramón y Cajal ( Site 4802)
Madrid Madrid, Comunidad De, 28034, Spain
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)
Genève Geneve, 1211, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)
Lausanne Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 4601)
Zurich , 8058, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

300

Study ID:

NCT04700072

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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