Open Actively Recruiting

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)

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
120 Years

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

Join this Trial

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Study Stats
Protocol No.
21-000531
Category
Hematology-Oncology
Oncology
Contact
Elizabeth Seja
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04700072
For detailed technical eligibility, visit ClinicalTrials.gov.