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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
Complete resection of all Ta/T1 papillary disease (including participants with concurrent CIS), with most recent positive TURBT occurring within 12 weeks prior to randomization or study intervention. A second TURBT must have been performed if indicated according to the current locally applicable guidelines, ie, American Urological Association, European Association of Urology
(Cohorts B1 and B2 only): Histological confirmed diagnosis of BCG-unresponsive high-risk, non-muscle invasive TCC of the urothelium within 12 months (CIS only) or 6 months (recurrent Ta/T1 disease) of completion of adequate BCG therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up registration to 5 years after last participant randomized.
Awards & highlights

CREST 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.Check my eligibility
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.See study design
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.

CREST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had all my bladder tumors surgically removed recently.
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My bladder cancer is high-risk, not invasive, and didn't respond to BCG therapy.
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My bladder cancer is mainly transitional cell type and considered high risk.
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I cannot or have chosen not to undergo major bladder surgery.

CREST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 A: Arm B compared to Arm C)
+1 more
Secondary outcome measures
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)
+18 more

CREST 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
4,556 Previous Clinical Trials
10,906,613 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,088,050 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the literature say about the potential risks of PF-06801591?

"PF-06801591's safety is estimated to be a 3. This is due to the fact that this clinical trial is in Phase 3, which suggests that there is both efficacy data and multiple rounds of safety data available."

Answered by AI

Are people still welcome to sign up and participate in this research?

"Right now, this clinical trial needs participants. The first posting was on December 30th 2019 with the most recent update being October 17th 2020."

Answered by AI

Can you tell me how many medical facilities are testing this new treatment?

"Presently, this research is being conducted at UPMC Urology in Pittsburgh, Pennsylvania; University of Minnesota Medical Center, Fairview IDS Pharmacy in Columbia, Missouri; and University of Missouri - Ellis Fischel Cancer Center in Oklahoma City, Oklahoma. In addition to these locations, the study is also running out of 14 other sites."

Answered by AI
~40 spots leftby Jun 2024