2024-513160-25-00Active, not recruitingPhase 3
A study to continue providing GME751 (a new medicine that is similar to pembrolizumab) to participants who are eligible for pembrolizumab treatment after participation in previous studies (CGME751A12101 or CGME751A12301)
An open-label, multi-center, single arm, rollover study of GME751 (proposed pembrolizumab biosimilar) in participants who are eligible for continued pembrolizumab treatment after participation in CGME751A12101 or CGME751A12301 studies.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 25 Aug 2026
Brief summary (registry, in English)
To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- 30 Oct 2024
- Lead sponsor
- H e x a l AG
- Diseases
- Lung cancer, Melanoma
- EU CT number
- 2024-513160-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 81
- 27 sites in 3 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.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants who experienced disease recurrence during Study 101 or Study 301
- Participants who experienced disease progression during Study 301
Other
- Participants who experienced unacceptable toxicity related to pembrolizumab during Study 101 or Study 301
- Participants who have full reimbursable access to Keytruda for their indication.
Who the study is looking for
- Signed informed consent must be obtained prior to participation in the study.
- Participant must be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) on the day of signing informed consent.
- Participants of Study 101 or Study 301 who are judged to benefit from continued treatment with pembrolizumab by their Investigator.
- Participants who have demonstrated compliance with Study 101 or Study 301 protocol requirements as assessed by their Investigator.
- Participants who completed Study 101 or Study 301 as per protocol OR who discontinued treatment and consequently study participation in Study 101 or 301 Note: Examples for discontinued participants: • Study 101, e.g. participants who did not receive pembrolizumab within the predefined visit schedule window, • Study 301, e.g. participants with unacceptable toxicity to background chemotherapy Cis-/Carboplatin and/or Pemetrexed.
- Participants who discontinued from Study 301 based on Sponsor´s decision to terminate Study 301
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro | A Coruna | Spain | Active, not recruiting |
| Institut Catala d'Oncologia | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Active, not recruiting |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Active, not recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Active, not recruiting |
| Klaipedos universiteto ligonine VšĮ | Klaipeda | Lithuania | Completed |
| Nacionalinis Vezio Institutas | Vilnius | Lithuania | Completed |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti | Bucharest | Romania | Active, not recruiting |
| Medisprof S.R.L. | Cluj-Napoca | Romania | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. | Craiova | Romania | Active, not recruiting |
| Oncolab S.R.L. | Craiova | Romania | Active, not recruiting |
| Onco Clinic Consult S.A. | Craiova | Romania | Active, not recruiting |
| Radiotherapy Center Cluj S.R.L. | Floresti | Romania | Active, not recruiting |
| Centrul De Oncologie-Euroclinic S.R.L. | Iasi | Romania | Active, not recruiting |
| Oncomed S.R.L. | Timisoara | Romania | Active, not recruiting |
| Oncocenter Oncologie Clinica S.R.L | Timișoara | Romania | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.