Master Protocol for Avelumab Continuation Study.

Phase 3

Active, not recruiting

• Conditions: Cancer

• Registration Number: 2023-509466-38-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

To monitor the safety and tolerability of study intervention(s)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-07
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

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.

Exclusion Criteria

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
AEs leading to permanent discontinuation of study intervention		AEs leading to permanent discontinuation of study intervention
All SAEs		All SAEs

Trial Locations

Locations (11)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Grand Hopital De Charleroi; 🇧🇪 Charleroi, Belgium

Orszagos Onkologiai Intezet; 🇭🇺 Budapest XII, Hungary

Azienda Ospedaliero Universitaria Delle Marche; 🇮🇹 Ancona, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori; 🇮🇹 Milan, Italy

Humanitas Mirasole S.p.A.; 🇮🇹 Rozzano, Italy

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji; 🇵🇱 Warsaw, Poland

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen De Valme; 🇪🇸 Sevilla, Spain

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Aalborg University Hospital

🇩🇰Aalborg, Denmark

Andreas Carus

Site contact

+97660000

andreas.carus@rn.dk