NCT06153238CompletedPhase 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 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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 322 (actual)
- First submitted
- 11 Oct 2023
- Start date
- 15 May 2024
- Primary completion date
- 5 May 2026
- Lead sponsor
- Sandoz
- Diseases
- Melanoma
- NCT number
- NCT06153238
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 322
- From 15 May 2024 to the primary completion date, 5 May 2026
- 61 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known history of hypersensitivity (grade ≥3) to pembrolizumab or its excipients
- Known History of auto-immune disease
- Active autoimmune disease that has necessitated chronic systemic treatment within 2 years before the first study treatment
- Other protocol-defined inclusion/exclusion criteria apply
Other
- Known history or evidence of ocular or uveal melanoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Canoas | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Itajaí | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Porto Velho | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Batumi | Georgia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Rozzano | Italy | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Klaipėda | Lithuania | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Skopje | North Macedonia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Oaxaca City | Mexico | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | George Town | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Malacca | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Bacolod | Philippines | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Phoenix | South Africa | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Mostar | Bosnia and Herzegovina | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Sarajevo | Bosnia and Herzegovina | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Tuzla | Bosnia and Herzegovina | Unknown status |
| Sandoz Investigational Site Coordinator of this site? Confirm its status | Yüreğir | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.