Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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 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.

Official Title

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

Keywords

Non-muscle Invasive Bladder Cancer CREST Sasanlimab PF-06801591 Bacillus Calmette Guerin BCG Bladder cancer Urinary Bladder Neoplasms BCG Vaccine Bacillus Calmette-Guerin PF-06801591 + BCG induction and maintenance PF-06801591 + BCG induction only BCG induction and maintenance

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Urological Associates of Southern Arizona P.C. not yet accepting patients
    Tucson Arizona 85741 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04165317
Phase
Phase 3
Study Type
Interventional
Last Updated