Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
Sponsor: Pfizer
ClinicalTrials ID:NCT05059522
The B9991046 master protocol facilitates continued access to Avelumab and other treatments for eligible participants from closing Pfizer-sponsored studies. Participants must show clinical benefit, comply with reproductive criteria, and adhere to study procedures. Interventions include oral drugs like Lorlatanib and IV infusions such as Utomilumab, ensuring comprehensive follow-up.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Description
B9991046 is a master protocol that will consist of sub-studies from the following parent studies:
B9991001 - NCT02603432 B9991003 - NCT02684006 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group, PA | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group, PA | 72758 | Rogers | Arkansas |
| Highlands Oncology Group, PA | 72762 | Springdale | Arkansas |
| UCLA Hematology/Oncology | 90095 | Los Angeles | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| MSK Basking Ridge | 07920 | Basking Ridge | New Jersey |
| MSK Monmouth | 07748 | Middletown | New Jersey |
| MSK Bergen | 07645 | Montvale | New Jersey |
| MSK Commack | 11725 | Commack | New York |
| MSK Westchester | 10604 | Harrison | New York |
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