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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: 2021-002457-29
  • NTC ID: NCT05059522
  • Sponsor: Pfizer
To obtain contact information for a study center near you, click here.

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:
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.

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: Highlands Oncology Group, PA
Fayetteville, Arkansas 72703
United States
Status: Recruiting Contact: N/A
Facility: Highlands Oncology Group, PA
Rogers, Arkansas 72758
United States
Status: Recruiting Contact: N/A
Facility: Highlands Oncology Group, PA
Springdale, Arkansas 72762
United States
Status: Recruiting Contact: N/A
Facility: UCLA Hematology/Oncology - Administrative Office
Los Angeles, California 90024
United States
Status: Recruiting Contact: N/A
Facility: Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: UCLA Hematology/Oncology
Los Angeles, California 90095
United States
Status: Recruiting Contact: N/A
Facility: MSK Basking Ridge
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: N/A
Facility: MSK Monmouth
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: N/A
Facility: MSK Bergen
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: N/A
Facility: MSK Commack
Commack, New York 11725
United States
Status: Recruiting Contact: N/A
Facility: MSK Westchester
Harrison, New York 10604
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
Long Island City, New York 11101
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York 10021
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York 10022
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: N/A
Facility: MSK Nassau
Uniondale, New York 11553
United States
Status: Recruiting Contact: N/A
Facility: Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: N/A
Facility: The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: N/A
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: Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
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: Institut de Cancérologie de Lorraine Alexis Vautrin
Vandoeuvre-lès-Nancy, Lorraine 54519
France
Status: Recruiting Contact: N/A
Facility: Országos Onkológiai Intézet
Budapest, Milano 1122
Hungary
Status: Recruiting Contact: N/A
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Tokyo 20133
Italy
Status: Recruiting Contact: N/A
Facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona, Tokyo 60126
Italy
Status: Recruiting Contact: N/A
Facility: National Cancer Center Hospital
Chuo-ku, Incheon-gwangyeoksi [incheon] 104-0045
Japan
Status: Recruiting Contact: N/A
Facility: Japanese Foundation for Cancer Research
Koto, Kyǒnggi-do 135-8550
Japan
Status: Recruiting Contact: N/A
Facility: Oita University Hospital
Yufu, Seoul-teukbyeolsi [seoul] 879-5593
Japan
Status: Recruiting Contact: N/A
Facility: Gachon University Gil Medical Center
Namdong-gu, Seoul-teukbyeolsi [seoul] 21565
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: National Cancer Center
Goyang-si, Seoul-teukbyeolsi [seoul] 10408
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Seoul National University Bundang Hospital
Seongnam, Stavropol'skiy KRAY 13620
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Asan Medical Center
Seoul, Barcelona [barcelona] 05505
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Samsung Medical Center
Seoul, 06351
Korea, Republic of
Status: Recruiting Contact: N/A
Facility: Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Clínic de Barcelona
Barcelona, 08036
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Virgen de Valme
Sevilla, 41014
Spain
Status: Recruiting Contact: N/A
Facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, NE7 7DN
United Kingdom
Status: Recruiting Contact: N/A
Facility: Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ
United Kingdom
Status: Recruiting Contact: N/A