Master Protocol for Avelumab Continuation Study

Phase 1

• 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-HU
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participants are eligible to be included in the study only if all the following criteria apply:
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

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
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