Active — Not RecruitingPhase 3

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

United States68 participantsStarted 2021-09-29

Plain-language summary

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Any participant who is receiving study treatment and deriving significant clinical benefit 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.
✓. Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

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.

What they're measuring

Number of participants with adverse events leading to permanent discontinuation of study intervention

Timeframe: Baseline up to approximately 5 years

Number serious adverse events reported for all participants

Timeframe: Baseline up to approximately 5 years

Trial details

NCT IDNCT05059522

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

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