Clinical trial · Interventional
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
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
NCT06153238CI-TRIAL-00117103completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GME751 | Drug | Pembrolizumab | ALIAS |
| Keytruda - EU | Drug | — | UNRESOLVED |
| Keytruda - US | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- GME751
- description
- Subjects will receive GME751 via intravenous (IV) infusion.
- interventionNames
- Drug: GME751
- type
- ACTIVE_COMPARATOR
- label
- Keytruda - EU
- description
- Subjects will receive Keytruda-EU via intravenous (IV) infusion.
- interventionNames
- Drug: Keytruda - EU
- type
- ACTIVE_COMPARATOR
- label
- Keytruda - US
- description
- Subjects will receive Keytruda-US via intravenous (IV) infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.