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)

• Status: Recruiting
• Trial end date: 2030-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Lenvatinib; Pembrolizumab

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

• 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