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

JRCT ID: jRCT2071200044

Registered date:20/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non-muscle Invasive Bladder Cancer
• Date of first enrollment: 01/12/2020
• Target sample size: 1070
• Countries of recruitment: Australia,Japan,Belgium,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Italy,Japan,Korea, Republic of,Japan,Poland,Japan,Russian Federation,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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: Sasanlimab]

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04165317