Non-muscle Invasive Bladder Cancer
Conditions
Interventions
Cohort A:
Arm A: PF-06801591 + BCG (induction and maintenance)
Arm B: PF-06801591 + BCG (induction only)
Arm C: BCG (induction and maintenance)
Cohort B:
PF-06801591
[Other name of PF-06801591: Sasanl
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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) 2. Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology 3. (Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy. 4. (Cohorts B1 and B2 only): Have refused or are ineligible for radical cystectomy
Exclusion criteria
Exclusion criteria: 1. Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium 2. (Cohort A only): Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical chemotherapy for NMIBC is allowed. 3. (Cohorts B1 and B2 only): Any systemic or intravesical chemotherapy or immunotherapy from the time of most recent positive TURBT to initiation of study intervention. 4. Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody 5. Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15, interferon (INF) 6. Prior radiation therapy to the bladder 7. (Cohorts B1 and B2 only): Prior participation in Cohort A of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Event free survival (EFS) of Arm A compared to Arm C Cohort B: Complete response (CR) rate in cohort B1 and EFS in cohort B2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. (Cohort A) EFS of Arm B compared to Arm C 2. (Cohort A) Overall survival (OS) of Arm A and Arm B compared to Arm C 3. (Cohort A) CR in participants with CIS at randomization 4. (Cohort A) Time to recurrence of low grade disease 5. Time to cystectomy 6. (Cohort A) Disease-specific survival (DSS) 7. Health-related quality of life 8. (Cohort A Arms A and B) PK and Immunogenicity 9. PD-L1 Status 10. Safety profile (adverse events, laboratory test abnormalities) 11. (Cohort B1) CR rate 12. (Cohort B1 and B2) EFS 13. (Cohort B1 and B2) OS 5 and 7~13: Obsolete for Cohort B after stopping enrollment | — |
Countries
Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed