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Active, Not Recruiting

NCT Number: NCT05059522

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced Malignancies Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders NSCLC Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Solid Tumors Urogenital Diseases Urogenital Neoplasms Urothelial Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Macquarie University, North Ryde, New South Wales, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avelumab

Drug

oral

Lorlatanib

Drug

oral

Talazoparib

Drug

oral

Pemetrexed

Drug

IV (intravenous) infusion

Axitinib

Drug

oral

CMP 001

Drug

IT (intratumoral) or SC (subcutaneous)

Utomilumab

Drug

IV infusion

PF04518600

Drug

IV infusion

Primary outcomes

  1. Number of participants with adverse events leading to permanent discontinuation of study intervention

    Time frame: Baseline up to approximately 5 years

  2. Number serious adverse events reported for all participants

    Time frame: Baseline up to approximately 5 years

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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