Sasanlimab (PF-06801591) in Combination With BCG or as Single Agent in Participants With High-Risk Non-Muscle Invasive Bladder Cancer

Phase 3

Active, not recruiting

• Conditions: on-muscle Invasive Bladder Cancer

• Registration Number: JPRN-jRCT2071200044
• Lead Sponsor: Kawai Norisuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 1067

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort A:<br>Event free survival (EFS) of Arm A and Arm B compared to Arm C<br>Cohort B:<br>Complete response (CR) rate in cohort B1 and EFS in cohort B2

Secondary Outcome Measures

Name	Time	Method
1. (Cohort A) Overall survival (OS) of Arm A and Arm B compared to Arm C<br>2. (Cohort A) CR in participants with CIS at randomization<br>3. (Cohort A) Time to recurrence of low grade disease<br>4. Time to cystectomy<br>5. (Cohort A) Disease-specific survival (DSS)<br>6. Health-related quality of life<br>7. (Cohort A Arms A and B) PK and Immunogenicity<br>8. PD-L1 Status<br>9. Safety profile (adverse events, laboratory test abnormalities)<br>10. (Cohort B1) CR rate<br>11. (Cohort B1 and B2) EFS<br>12. (Cohort B1 and B2) OS<br>4 and 6~12: Obsolete for Cohort B after stopping enrollment