2023-509466-38-00RecruitingPhase 3
B9991046 - AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 14
- Locations
- 11
- Primary Endpoint
- AEs leading to permanent discontinuation of study intervention
Study Overview
Brief Summary
To monitor the safety and tolerability of study intervention(s)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
- •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.
- •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.
Exclusion Criteria
- •Female participants who are pregnant or breastfeeding.
- •Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.
Outcomes
Primary Outcomes
AEs leading to permanent discontinuation of study intervention
AEs leading to permanent discontinuation of study intervention
All SAEs
All SAEs
Secondary Outcomes
No secondary outcomes reported
Investigators
Clinical Medical Lead
Scientific
Pfizer Inc.
Study Sites (11)
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