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NCT06153238 · ClinicalTrials.gov registry record · Phase 1
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 Phase 1 study of Melanoma, sponsored by Sandoz.
- Active
- Registry status
- Phase 1
- Development phase
- 322
- Enrollment target
- 20
- Study locations
NCT06153238: Active Phase 1 study of Melanoma, sponsored by Sandoz.
NCT06153238 is a Phase 1 study of Melanoma that is active but no longer recruiting, run by Sandoz. The registered enrollment target is 322 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06153238, a Phase 1 study of Melanoma, is active but no longer recruiting, sponsored by Sandoz.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 322 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
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 |
What the registry record for NCT06153238 still lists
NCT06153238 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (54% lower).
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.
NCT06153238 names 20 study sites across 3 states, led by Other, Florida, California.
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.
What interventions are being tested in trial NCT06153238?
The interventions under investigation include: GME751 (DRUG), Keytruda - EU (DRUG), Keytruda - US (DRUG).
Who is sponsoring clinical trial NCT06153238?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06153238's enrollment target sits among peer trials
322 51st of 266 higher than 216 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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