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Monoclonal Antibodies

Sasanlimab for Bladder Cancer (CREST Trial)

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have refused or are ineligible for radical cystectomy
Be older than 18 years old
Must not have
Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or concurrent extravesical, non-muscle invasive TCC of the urothelium
Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 60 months from last participant randomized
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing the safety and effects of sasanlimab in people with early stage bladder cancer that is high risk or has been previously treated with BCG.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical ones from similar treatments may include immune reactions, irritation at injection site, flu-like symptoms such as fever and chills, fatigue, and potential infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot or have chosen not to undergo major bladder surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread beyond the bladder lining or is in advanced stages.
Select...
I have previously received immunotherapy targeting PD-1, PD-L1, PD-L2, or CTLA-4.
Select...
I have previously been treated with immune-stimulating drugs like IL-2 or interferon.
Select...
I have had radiation therapy targeting my bladder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization/registration to date of cystectomy (up to 5 years after last participant is randomized)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization/registration to date of cystectomy (up to 5 years after last participant is randomized) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete response rate (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Event free survival (Cohort A: Arm A compared to Arm C)
Event free survival (Cohort B2) (Obsolete after stopping enrollment in Cohort B)
Secondary study objectives
Complete response rate at 12 months (Cohort B1) (Obsolete after stopping enrollment in Cohort B)
Complete response rate in participants with CIS at randomization (Cohort A: Arm A, B, C)
Disease-specific survival (Cohort A: Arm A, B, C)
+19 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Bacillus Calmette Guerin (induction and maintenance).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06801591
2023
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,860,854 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,901,856 Total Patients Enrolled

Media Library

Sasanlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04165317 — Phase 3
Bladder Cancer Research Study Groups: PF-06801591 + BCG induction only, BCG induction and maintenance, PF-06801591 + BCG induction and maintenance, BCG Unresponsive NMIBC, BCG Unresponsive CIS
Bladder Cancer Clinical Trial 2023: Sasanlimab Highlights & Side Effects. Trial Name: NCT04165317 — Phase 3
Sasanlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165317 — Phase 3
~181 spots leftby Dec 2025
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