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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.

Location

Facility Status Contact
Urology San Antonio PA
San Antonio, Texas 78229
United States
Recruiting