2023-506881-30-00CompletedPhase 1
A Pharmacokinetics (PK) study to compare GME751 (proposed pembrolizumab biosimilar) and United States (US)-licensed and European Union (EU)-approved Keytruda®in participants with stage Ⅱ and Ⅲ skin cancer requiring adjuvant treatment (therapy applied after initial treatment of cancer to suppress the regrowth of tumor) with pembrolizumab.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Nov 2025
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 136 (actual)
- First submitted
- 30 Nov 2023
- Start date
- 15 May 2024
- Lead sponsor
- H e x a l AG
- Diseases
- Melanoma
- EU CT number
- 2023-506881-30-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 136
- 25 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Completed |
| Fachklinik Hornheide e.V. | Muenster | Germany | Completed |
| Eberhard Karls Universitaet Tuebingen | Tuebingen | Germany | Completed |
| Institut Catala d'Oncologia | Badalona | Spain | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Completed |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Fundación Instituto Valenciano de Oncología | Valencia | Spain | Completed |
| Hospital Unviersitario Miguel Servet | Zaragoza | Spain | Completed |
| Besancon University Hospital Center | Besancon Cedex | France | Completed |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Completed |
| Azienda Ospedaliera Universitaria Mater Domini | Catanzaro | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Completed |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Completed |
| Humanitas Research Hospital | Rozzano | Italy | Completed |
| Klaipedos universiteto ligonine VšĮ | Klaipeda | Lithuania | Completed |
| Nacionalinis Vezio Institutas | Vilnius | Lithuania | Completed |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti | Bucharest | Romania | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.