Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, 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

  • Sulpizio Cardiovascular Center at UC San Diego Health not yet accepting patients
    La Jolla California 92037 United States
  • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) not yet accepting patients
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • UC San Diego Medical Center - Hillcrest not yet accepting patients
    San Diego California 92103 United States
  • Koman Family Outpatient Pavilion not yet accepting patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT04165317
Phase
Phase 3
Study Type
Interventional
Last Updated