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BRIEF TITLE: 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

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


  • Org Study ID: B8011006
  • Secondary ID:
  • NCT ID: NCT04165317
  • NCT Alias:
  • Sponsor: Pfizer - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting December 30, 2019 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Event free survival (Arm A compared to Arm C)

Primary Outcome 1 - Time Frame: Randomization up to 55 months

Primary Outcome 2 - Measure: Event free survival (Arm B compared to Arm C)

Primary Outcome 2 - Time Frame: Randomization up to 55 months

Condition:

  • Non-muscle Invasive Bladder Cancer

Eligibility

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Link: To obtain contact information for a study center near you, click here.

Locations

Facility Status Contact
Urological Associates of Southern Arizona, P.C .
Tucson, Arizona 85715
United States
Not yet recruiting
Urological Associates of Southern Arizona P.C.
Tucson, Arizona 85741
United States
Not yet recruiting
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois 60612
United States
Not yet recruiting
Regional Urology Oncology & Radiation Center
Shreveport, Louisiana 71106
United States
Not yet recruiting
Regional Urology, LLC
Shreveport, Louisiana 71106
United States
Not yet recruiting
Associated Medical Professionals of New York, PLLC
Syracuse, New York 13210
United States
Not yet recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania 17604
United States
Not yet recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting
Parkway Surgery Center
Myrtle Beach, South Carolina 29572
United States
Recruiting
Houston Metro Urology
Houston, Texas 77027
United States
Not yet recruiting
Urology San Antonio PA
San Antonio, Texas 78229
United States
Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Recruiting
Urology of Virginia, PLLC
Virginia Beach, Virginia 23462
United States
Recruiting