Sasanlimab for Bladder Cancer
(CREST Trial)

Recruiting in Palo Alto (17 mi)

+221 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. * One group is given sasanlimab and BCG at the study clinic. * The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. * The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. - Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Eligibility Criteria

This trial is for people with early-stage bladder cancer that hasn't spread, was surgically removed, and is high risk. Participants must have had BCG treatment but can't join if they've had prior radiation to the bladder, muscle-invasive or advanced cancer, certain other treatments like immunotherapy, or participated in part A of this study.

Inclusion Criteria

My bladder cancer is high-risk, not invasive, and didn't respond to BCG therapy.

I had all my bladder tumors surgically removed recently.

My bladder cancer is mainly transitional cell type and considered high risk.

+1 more

Exclusion Criteria

My cancer has spread beyond the bladder lining or is in advanced stages.

I have previously received immunotherapy targeting PD-1, PD-L1, PD-L2, or CTLA-4.

I have previously been treated with immune-stimulating drugs like IL-2 or interferon.

+4 more

Participant Groups

The study tests sasanlimab's safety and effects on non-muscle invasive bladder cancer. It has two parts: Part A (closed) compared sasanlimab plus BCG against BCG alone; Part B assigns new participants based on tumor type to receive sasanlimab at the clinic.

5Treatment groups

Experimental Treatment

Active Control

Group I: PF-06801591 + BCG induction onlyExperimental Treatment2 Interventions

PF-06801591 in combination with Bacillus Calmette Guerin (induction only).

Group II: PF-06801591 + BCG induction and maintenanceExperimental Treatment2 Interventions

PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).

Group III: BCG Unresponsive NMIBCExperimental Treatment1 Intervention

PF-06801591

Group IV: BCG Unresponsive CISExperimental Treatment1 Intervention

PF-06801591

Group V: BCG induction and maintenanceActive Control1 Intervention