BridgeMD
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)
EU CTIS ID: 2024-513160-25-00
What this study is testing
To descriptively assess the safety of continued treatment with GME751, based on the occurrence of SAEs
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bosnia and Herzegovina
- Taiwan
- Vietnam
- Turkey
- Serbia
- United States
- Brazil
- Japan
- Korea, Republic of
- Moldova, Republic of
- Georgia
- South Africa
- India
- Thailand
- Malaysia
- North Macedonia
- Mexico
- Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bosnia and Herzegovina; Taiwan; Vietnam; Turkey; Serbia; United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.