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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of upper tract urothelial cancer or cancer within the prostatic urethra as documented by imaging studies performed within 6 months of enrollment
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, PF-07225570, to see if it is safe and effective against bladder cancer when used alone or in combination with another drug.
Eligible Conditions
- Bladder Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with AEs according to Relationship
Number of Participants with AEs according to Seriousness
Number of Participants with Adverse Events (AEs) according to Severity
+1 moreSecondary outcome measures
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07225570 after a single dose
Area under the curve from specified time to steady state (AUCτ,ss) of PF-07225570 after multiple doses
Concentration from maximum to steady state (Cmax,ss) of PF-07225570 after multiple doses
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 2B PF-07225570 and sasanlimabExperimental Treatment2 Interventions
PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion
Group II: Part 2A PF-07225570 monotherapyExperimental Treatment1 Intervention
IVe Single Agent Dose Expansion
Group III: Part 1B PF-07225570 and sasanlimabExperimental Treatment2 Interventions
PF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation
Group IV: Part 1A PF-07225570 monotherapyExperimental Treatment1 Intervention
Intravesical (IVe) Single Agent Dose Escalation
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,683 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,120 Total Patients Enrolled
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