Study of Sasanlimab (PF-06801591) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-Risk Non-Muscle Invasive Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Dec 2, 2026
  • participants needed
    999
  • sponsor
    Pfizer
Updated on 29 November 2020
Investigator
Pfizer CT.gov Call Center
Primary Contact
Polyclinique de Limoges Site Chenieux (1.2 mi away) Contact
+110 other location

Summary

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment

Phase 3 Design with 3 study Arms (A, B and C). Arms A and B consists of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG.

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 nave 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.

Details
Treatment PF-06801591, bacillus Calmette-Guérin
Clinical Study IdentifierNCT04165317
SponsorPfizer
Last Modified on29 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non Muscle Invasive Bladder Cancer?
Do you have any of these conditions: Do you have Non Muscle Invasive Bladder Cancer??
Do you have any of these conditions: Do you have Non Muscle Invasive Bladder Cancer??
Do you have any of these conditions: Do you have Non Muscle Invasive Bladder Cancer??
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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