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A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
NCT06153238 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG GME751
- DRUG Keytruda - EU
- DRUG Keytruda - US
Study Locations (20)
Other
- Sandoz Investigational Site — Banja Luka
- Sandoz Investigational Site — Mostar
- Sandoz Investigational Site — Sarajevo
- Sandoz Investigational Site — Tuzla
- Sandoz Investigational Site — Barretos
- Sandoz Investigational Site — Belo Horizonte
- Sandoz Investigational Site — Canoas
- Sandoz Investigational Site — Caxias do Sul
- Sandoz Investigational Site — Curitiba
- Sandoz Investigational Site — Florianópolis
- Sandoz Investigational Site — Fortaleza
- Sandoz Investigational Site — Itajaí
- Sandoz Investigational Site — Porto Alegre
- Sandoz Investigational Site — Porto Velho
- Sandoz Investigational Site — Salvador
- Sandoz Investigational Site — São José do Rio Preto
- Sandoz Investigational Site — Besançon
Florida
- Sandoz Investigational Site — Clermont
- Sandoz Investigational Site — Orange City
California
- Sandoz Investigational Site — Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06153238
The ClinicalTrials.gov registry entry for NCT06153238 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions — of which GME751 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06153238 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06153238 about?
NCT06153238 is a clinical study titled "A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma". 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.
What is the current status of trial NCT06153238?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 322 participants. The study started on 2024-05-15. Estimated completion is 2026-06.
What conditions does trial NCT06153238 study?
This clinical trial studies the following conditions: Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06153238?
The interventions under investigation include: GME751 (DRUG), Keytruda - EU (DRUG), Keytruda - US (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06153238?
This trial is sponsored by Sandoz, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06153238 being conducted?
This trial has 20 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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