Master Protocol for Avelumab Continuation Study
- Conditions
- This Master Protocol for Avelumab Continuation Sub-Studies has been designed to accommodate continued access to study intervention, safety follow-up, and when applicable, overall survival follow up, for eligible participants receiving study intervention and who continue to derive treatment benefit or who are in follow-up in a Pfizer-sponsored avelumab study (Parent Study)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002457-29-BE
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1.Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
2.Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Avelumab Continuation Sub-Study Protocol.
3.Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub-Study Protocol.
4.Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Female participants who are pregnant or breastfeeding.
2.Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To monitor the safety and tolerability of study intervention(s). A maximum of 9 sub studies and a maximum of 300 participants will be included in this Master Protocol for Avelumab Continuation Sub-Studies:<br>B9991009 To monitor the safety and tolerability of avelumab.<br>B9991025 To monitor the safety and tolerability of avelumab and talazoparib.<br>;Secondary Objective: Current sub-protocols (included in this submission)<br>B9991009 - not applicable<br>B9991025 - not applicable<br>;Primary end point(s): AEs leading to permanent discontinuation of study intervention<br>All SAEs<br><br>Current sub-protocols (included in this submission)<br>B9991009:<br>- AEs leading to permanent discontinuation of avelumab<br><br>B9991025:<br>- AEs leading to permanent discontinuation of avelumab and/or talazoparib<br>- SAEs;Timepoint(s) of evaluation of this end point: N/A
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A