A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Launched by SANDOZ · Nov 22, 2023

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ClinConnect Summary

This clinical trial is studying a new medication called GME751, which is a proposed biosimilar to Keytruda® (pembrolizumab), a treatment used for advanced melanoma. The goal of the trial is to see how similar GME751 is to Keytruda® in terms of how the body processes the drug, as well as its safety and effectiveness in patients who have had their melanoma surgically removed. This study is currently recruiting participants who are adults aged 18 and older, have advanced melanoma that was completely removed within the last 13 weeks, and have a good performance status.

To be eligible, participants should not have a history of certain types of melanoma, serious allergic reactions to pembrolizumab, or active autoimmune diseases. Those who have received specific treatments or vaccines recently might also be excluded. If you join this trial, you can expect to receive either GME751 or Keytruda® and will be closely monitored for any side effects or responses to the treatment. This study aims to provide important information that could help improve treatment options for patients with melanoma in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • At least 18 years of age
• • Advanced Melanoma
• • Completely removed melanoma by surgery performed within 13 weeks of randomization
• • Adequate organ function
• • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Exclusion Criteria:
• • Known history or evidence of ocular or uveal melanoma
• • Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
• • Known History of auto-immune disease
• • Received live vaccine ≤30 days before the first study treatment
• • Prior treatment with anti-PD-1 agents or agent against another stimulatory or co-inhibitory T cell receptor
• • Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
• • Other protocol-defined inclusion/exclusion criteria apply