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

Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.

INTRODUCTION

  • Org Study ID: B9991046
  • Secondary ID: N/A
  • NCT ID: NCT05059522
  • Sponsor: Pfizer

BRIEF 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.

DETAILED DESCRIPTION

B9991046 is a master protocol that will consist of sub-studies from the following parent studies:

B9991001 - NCT02603432 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991

  • Overall Status
    Recruiting
  • Start Date
    September 29, 2021
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with adverse events leading to permanent discontinuation of study intervention

Primary Outcome 1 - Timeframe: Baseline up to approximately 5 years

Primary Outcome 2 - Measure: Number serious adverse events reported for all participants

Primary Outcome 2 - Timeframe: Baseline up to approximately 5 years

CONDITION

  • Advanced Malignancies
  • NSCLC
  • Ovarian Cancer
  • Urothelial Cancer
  • Solid Tumors

ELIGIBILITY

Inclusion Criteria:
1. 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.

- 2. Participants must agree to follow the reproductive criteria.

- 3. Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION

Facility Status Contact
Facility: The Prince Charles Hospital
Chermside, Queensland 4032
Australia
Status: Recruiting Contact: N/A
Facility: Grand Hôpital de Charleroi
Charleroi, Hainaut 6000
Belgium
Status: Recruiting Contact: N/A
Facility: Kingston Health Sciences Centre-Kingston General Hospital Site
Kingston, Ontario K7L 2V7
Canada
Status: Recruiting Contact: N/A
Facility: Aalborg Universitetshospital, Syd
Aalborg, Nordjylland 9000
Denmark
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Status: Recruiting Contact: N/A
Facility: Oita University Hospital
Yufu, Ōita 879-5593
Japan
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, Kyǒnggi-do 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 05505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona] 08035
Spain
Status: Recruiting Contact: N/A
Facility: National Cheng Kung University Hospital
Tainan, 704
Taiwan
Status: Recruiting Contact: N/A