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Comparing a new biosimilar to Keytruda for advanced melanoma treatment

A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab

Phase 1 Interventional Sandoz · NCT06153238

This study is testing a new treatment called GME751, which is similar to Keytruda, to see if it works as well and is safe for people with advanced melanoma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment318 (estimated)
Ages18 Years and up
SexAll
SponsorSandoz Industry-sponsored
Drugs / interventionspembrolizumab
Locations43 sites (Orange, California and 42 other locations)
Trial IDNCT06153238 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetic similarity, efficacy, safety, and immunogenicity of GME751, a proposed biosimilar to pembrolizumab (Keytruda), in patients with resected advanced melanoma. Participants will be randomly assigned to receive either GME751, FDA-licensed Keytruda, or EU-authorized Keytruda in a 1:1:1 ratio. The study will last approximately 28 weeks, including a 24-week treatment period with four cycles of therapy. Patients who respond well to treatment may continue receiving pembrolizumab based on local regulations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with completely resected stage II or III melanoma and adequate organ function.

Not a fit: Patients with ocular or uveal melanoma, a history of severe hypersensitivity to pembrolizumab, or active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more accessible and potentially cost-effective treatment option for patients with advanced melanoma.

How similar studies have performed: Other studies have shown success with biosimilars in oncology, suggesting that this approach may be promising.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Orange, California and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Melanoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.