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)

  • End date
    Apr 3, 2030
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 6 December 2021
metastatic melanoma
brain metastases


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) nave 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.

Condition Melanoma, Metastatic Melanoma, melanoma, Malignant Melanoma, skin cancer, Skin Cancer
Treatment Pembrolizumab, Lenvatinib, Quavonlimab, Pembrolizumab/Quavonlimab
Clinical Study IdentifierNCT04700072
SponsorMerck Sharp & Dohme Corp.
Last Modified on6 December 2021


Yes No Not Sure

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
Has not received more than 3 lines of therapy for metastatic melanoma
Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period
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

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
Clear my responses

How to participate?

Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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