Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    B8011006
Previous Study | Return to List | Next Study

Study of PF-06801591 in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer. (B8011006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165317
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 13, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE December 30, 2019
Estimated Primary Completion Date June 10, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Event free survival (Arm A compared to Arm C) [ Time Frame: Randomization up to 55 months ]
    Event free survival is defined as the time from randomization to date of EFS event.
  • Event free survival (Arm B compared to Arm C) [ Time Frame: Randomization up to 55 months ]
    Event free survival is defined as the time from randomization to date of EFS event.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2019)
  • Overall Survival (Arm A compared to Arm C) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
  • Overall Survival (Arm B compared to Arm C) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
  • Complete response in participants with CIS at randomization [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Number of CIS participants with complete response.
  • Disease-specific survival [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
  • Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire for cancer patients) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
  • ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. [ Time Frame: Randomization up to 24 months ]
    Ctrough will be summarized in Arms A and B only.
  • Incidence of ADA/Nab of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. [ Time Frame: Randomization up to 24 months ]
    Immunogenicity will be evaluated for Arms A and B only.
  • Tumor sample biomarker status based on PD-L1 expression (high or low) [ Time Frame: Baseline ]
    Evaluate PD-L1 expression.
  • Duration of CR for participants with CIS at randomization [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
  • Time to recurrence of low grade disease [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.
  • Time to cystectomy [ Time Frame: Randomization to date of cystectomy (up to 5 years after last participant is randomized) ]
    Time to cystectomy is defined as time from randomization to cystectomy in participants with NMIBC
  • Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) [ Time Frame: Randomization up to 24 months ]
    PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).
  • Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs [ Time Frame: Baseline up to 60 months from the last participant randomized ]
    An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
  • Percentage of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to 60 months from last participant randomized ]
    Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
  • Health-related quality of life as measured by EORTC QLQ-NMIBC24 9(European Organization for Treatment of Cancer in patients with non-muscle invasion bladder cancer) [ Time Frame: Randomization up to 60 months from the last participant randomized ]
    EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
  • Overall Survival (Arm A compared to Arm C) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
  • Overall Survial (Arm B compared to Arm C) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
  • Complete response in participants with CIS at randomization [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Number of CIS participants with complete response.
  • Disease-specific survival [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.
  • Health-related quality of life as measured by EORTC QLQ-C30 (European Organization for Treatment of Cancer Quality of Life Questionnaire) [ Time Frame: Randomization up to 60 months from last participant randomized ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).
  • ctrough of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. [ Time Frame: Randomization up to 24 months ]
    Ctrough will be summarized in Arms A and B only.
  • ADAs; NAbs of PF-06801591 when in combination with BCG (induction and maintenance or induction). Arms A and B only. [ Time Frame: Randomization up to 24 months ]
    Immunogenicity will be evaluated for Arms A and B only.
  • Tumor sample biomarker status based on PD-L1 expression (high or low) [ Time Frame: Baseline ]
    Evaluate PD-L1 expression.
  • Duration of CR for participants with CIS at randomization [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.
  • Time to recurrence of low grade disease [ Time Frame: Randomization up to 60 months from last participant randomized ]
    Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.
  • Time to cystectomy [ Time Frame: Randomization to date of cystectomy (up to 5 years after last participant is randomized) ]
    Time to cystectomy is defined as time from randomization to cystectomy in participants with NMIBC
  • Health-related quality of life as measured by PTAB (Patient Treatment Administration Burden Questionnaire) [ Time Frame: Randomization up to 24 months ]
    PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).
  • Percentage of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs [ Time Frame: Baseline up to 60 months from the last participant randomized ]
    An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
  • Percentage of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to 60 months from last participant randomized ]
    Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.
  • Health-related quality of life as measured by EORTC QLQ-NMIBC24 [ Time Frame: Randomization up to 60 months from the last particpant randomized ]
    EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Description Not 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2019)
999
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 9, 2026
Estimated Primary Completion Date June 10, 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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165317
Other Study ID Numbers  ICMJE B8011006
Has Data Monitoring Committee Yes
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP