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)
NCT ID: NCT04700072
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2021-05-03
2025-10-17
Brief Summary
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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.
As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab and quavonlimab) intravenously (IV) plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Pembrolizumab/Quavonlimab
Administered via IV infusion at a specified dose on specified days
Lenvatinib
Administered via oral capsule at a specified dose on specified days
Pembrolizumab + Lenvatinib
Participants will receive pembrolizumab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Lenvatinib
Administered via oral capsule at a specified dose on specified days
Interventions
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Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Pembrolizumab/Quavonlimab
Administered via IV infusion at a specified dose on specified days
Lenvatinib
Administered via oral capsule at a specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
120 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The Angeles Clinic and Research Institute ( Site 4009)
Los Angeles, California, United States
UCLA Hematology & Oncology ( Site 4004)
Los Angeles, California, United States
Providence Saint John's Health Center ( Site 4010)
Santa Monica, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 4012)
Aurora, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)
Baltimore, Maryland, United States
NYU Clinical Cancer Center ( Site 4002)
New York, New York, United States
Duke Cancer Institute ( Site 4005)
Durham, North Carolina, United States
Martha Morehouse Tower ( Site 4020)
Columbus, Ohio, United States
Inova Schar Cancer Institute ( Site 4011)
Fairfax, Virginia, United States
Calvary Mater Newcastle ( Site 4404)
Waratah, New South Wales, Australia
Melanoma Institute Australia ( Site 4402)
Wollstonecraft, New South Wales, Australia
Hopital La Timone ( Site 4103)
Marseille, Bouches-du-Rhone, France
CHU de Bordeaux- Hopital Saint Andre ( Site 4108)
Bordeaux, Gironde, France
Institut Claudius Regaud ( Site 4105)
Toulouse, Haute-Garonne, France
Centre Hospitalier Lyon Sud ( Site 4102)
Pierre-Bénite, Rhone, France
A.P.H. Paris, Hopital Saint Louis ( Site 4107)
Paris, , France
Gustave Roussy ( Site 4101)
Villejuif, Île-de-France Region, France
HaEmek Medical Center ( Site 4703)
Afula, , Israel
Rambam Health Care Campus-Oncology ( Site 4704)
Haifa, , Israel
Hadassah Ein Karem Jerusalem ( Site 4702)
Jerusalem, , Israel
Rabin Medical Center-Oncology ( Site 4705)
Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 4701)
Ramat Gan, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)
Milan, , Italy
Istituto Europeo di Oncologia ( Site 4301)
Milan, , Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)
Napoli, , Italy
Istituto Oncologico Veneto IRCCS ( Site 4355)
Padua, , Italy
Policlinico Le Scotte - A.O. Senese ( Site 4377)
Siena, , Italy
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4865)
Port Elizabeth, Eastern Cape, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4861)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 4863)
Sandton, Gauteng, South Africa
Cape Town Oncology Trials ( Site 4864)
Cape Town, Western Cape, South Africa
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 4801)
Barcelona, Catalonia, Spain
Hospital Universitario Ramón y Cajal ( Site 4802)
Madrid, Madrid, Comunidad de, Spain
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 4603)
Geneva, Canton of Geneva, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)
Lausanne, Canton of Vaud, Switzerland
Universitaetsspital Zuerich ( Site 4601)
Zurich, , Switzerland
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-02D
Identifier Type: OTHER
Identifier Source: secondary_id
KEYMAKER-U02
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506315-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1293-5704
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-003742-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-02D
Identifier Type: -
Identifier Source: org_study_id
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