Avelumab Master Protocol: An Open-Label Continuation Study for Participants Continuing from Pfizer-Sponsored Avelumab Clinical Studies

Study Identifier:
B9991046
CT.gov Identifier:
NCT05059522
EudraCT Identifier:
2021-002457-29
EU Trial (CTIS) Number:
2023-509466-38-00
Study Contact Information:
N/A
Recruitment Complete

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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Non-Small Cell Lung Cancer
  • Ovarian
  • Renal
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Arm 1
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  • Drug: Experimental: Arm 2
  • Drug: Drug: CMP 001
  • Drug: Drug: Utomilumab
  • Drug: Drug: PF04518600
  • Drug: Experimental: Arm 3
  • Drug: Drug: Lorlatanib
  • Drug: Experimental: Arm 4
  • Drug: Experimental: Arm 5
  • Drug: Drug: Talazoparib
  • Drug: Experimental: Arm 7
  • Drug: Drug: Axitinib
  • Drug: Experimental: Arm 8
  • Drug: Experimental: Arm 9
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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.
    • 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.
    • 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.
    • 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
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Non-Small Cell Lung Cancer
    Ovarian
    Renal
    Solid Tumor