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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. (B8011006)

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ClinicalTrials.gov Identifier: NCT04165317
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.


Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Drug: PF-06801591 Drug: Bacillus Calmette-Guerin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : December 23, 2019
Estimated Primary Completion Date : June 3, 2024
Estimated Study Completion Date : December 2, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: PF-06801591 + BCG induction and maintenance
PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).
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

Experimental: PF-06801591 + BCG induction only
PF-06801591 in combination with Bacillus Calmette Guerin (induction only).
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

Active Comparator: Bacillus Calmette Guerin
Bacillus Calmette Guerin (induction and maintenance).
Drug: Bacillus Calmette-Guerin
Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
Other Name: BCG




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. Tumor sample biomarker status based on PD-L1 expression (high or low) [ Time Frame: Baseline ]
    Evaluate PD-L1 expression.

  9. 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.

  10. 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.

  11. 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

  12. 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).

  13. 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.

  14. 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.

  15. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165317


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04165317     History of Changes
Other Study ID Numbers: B8011006
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
PF-06801591
Bacillus Calmette Guerin
BCG
Bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs