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Study of PF-06801591 in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer.

Last updated on December 6, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-muscle Invasive Bladder Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological confirmed diagnosis of high risk non-muscle invasive transitional cell
carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed
transitional/non-transitional cell histology are allowed, but TCC must be the
predominant histology)

- Complete resection of all Ta/T1 papillary disease (including participants with
concurrent CIS), with most recent TURBT occurring within 12 weeks prior to
randomization. A second TURBT must have been performed if indicated according to the
current locally applicable guidelines, ie, American Urological Association, European
Association of Urology

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or
concurrent extravesical, non-muscle invasive TCC of the urothelium

- Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical
chemotherapy for NMIBC is allowed

- Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody

- Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15,
interferon (INF)

- Prior radiation therapy to the bladder

NCT04165317
Pfizer
Not yet recruiting
Study of PF-06801591 in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer.

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Descriptive Information
Brief Title  ICMJE Study of PF-06801591 in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer.
Official Title  ICMJE A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer
Brief Summary

Phase 3 Design with 3 study Arms (A, B and C). The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC.

Arms A and B consists of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-muscle Invasive Bladder Cancer
Intervention  ICMJE
  • Drug: PF-06801591
    A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
  • Drug: Bacillus Calmette-Guerin
    Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
    Other Name: BCG
Study Arms  ICMJE
  • Experimental: PF-06801591 + BCG induction and maintenance
    PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
    Interventions:
    • Drug: PF-06801591
    • Drug: Bacillus Calmette-Guerin
  • Experimental: PF-06801591 + BCG induction only
    PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
    Interventions:
    • Drug: PF-06801591
    • Drug: Bacillus Calmette-Guerin
  • Active Comparator: Bacillus Calmette Guerin
    Bacillus Calmette Guerin (induction and maintenance).
    Intervention: Drug: Bacillus Calmette-Guerin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
999
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2, 2026
Estimated Primary Completion DateJune 3, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological confirmed diagnosis of high risk non-muscle invasive transitional cell carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed transitional/non-transitional cell histology are allowed, but TCC must be the predominant histology)
  • Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent TURBT occurring within 12 weeks prior to randomization. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology

Exclusion Criteria:

  • Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
  • Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed
  • Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
  • Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF)
  • Prior radiation therapy to the bladder
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165317
Other Study ID Numbers  ICMJE B8011006
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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