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)
Key facts
- Where
- A Coruna, Badalona, Barcelona, Cáceres, Córdoba, Madrid, Murcia, Oviedo, Santiago de Compostela, Sevilla, Valencia és Zaragoza, SpanyolországSee the 15 sites
- Phase
- 3. fázis
Where in Spanyolország
- Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y PineyroA Coruna, SpanyolországNo longer taking part
- Institut Catala d'OncologiaBadalona, SpanyolországNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországNo longer taking part
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital San Pedro De AlcántaraCáceres, SpanyolországNo longer taking part
- Hospital Universitario Reina SofiaCórdoba, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- University Clinical Hospital Virgen De La ArrixacaMurcia, SpanyolországNo longer taking part
- Hospital Universitario Central De AsturiasOviedo, SpanyolországNo longer taking part
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
- Fundación Instituto Valenciano de OncologíaValencia, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- H e x a l AG
- Trial code
- EU 2024-513160-25-00
- Record updated
- 2026. augusztus 25.
- Original description
To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEsRead full original descriptionShow less
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.
To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs
Inclusion: 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.
Exclusion: Participants who experienced disease recurrence during Study 101 or Study 301; Participants who experienced disease progression during Study 301; 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.