Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

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

Summary

Substudy 02B 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 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

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

Details

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

Criteria

Inclusion Criteria:

• Has histologically or cytologically confirmed melanoma

• Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy

• Has been untreated for advanced disease

• Has provided a tumor biopsy

• Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib; 7 days after lenvatinib is stopped, if participants are on pembrolizumab, pembrolizumab/quavonlimab, vibostolimab or a combination of the aforementioned drugs, no additional male contraception measures are needed

• 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, pembrolizumab/quavonlimab, vibostolimab, or 30 days after the last dose of lenvatinib, whichever occurs last

• Has adequate organ function

• Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy)

Exclusion Criteria:

• Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention

• Has a known additional malignancy that is progressing or requires active treatment within the past 2 years

• Has known central nervous system (CNS) metastases and/or carcinomatous meningitis

• Has ocular or mucosal melanoma

• Has an active autoimmune disease that has required systemic treatment in the past 2 years

• Has an active infection requiring systemic therapy

• Has known history of human immunodeficiency virus (HIV)

• Has known history of hepatitis B

• Has a history of (noninfectious) pneumonitis

• Has a history of active tuberculosis (TB)

• Has received prior systemic anticancer therapy within 4 weeks prior to randomization

• 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 vaccine within 30 days before the first dose of study intervention

• Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention

• Has had an allogeneic tissue/solid organ transplant

• Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study