Status:
WITHDRAWN
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Lead Sponsor:
Pfizer
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in p...
Eligibility Criteria
Inclusion
- Histological confirmed and documented diagnosis of non-muscle invasive urothelial carcinoma
- Participants with recurrent non-muscle invasive bladder cancer (intermediate risk or high risk)
- Ineligible for or elected not to undergo radical cystectomy
- 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
- Adequate bone marrow, renal and liver function
Exclusion
- Evidence of muscle-invasive, locally advanced or metastatic urothelial carcinoma or concurrent extravesical, non-muscle invasive urothelial carcinoma
- Macroscopic hematuria, traumatic catheterization or active urinary tract infection
- Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05259397
Start Date
March 24 2022
End Date
September 19 2022
Last Update
March 8 2023
Active Locations (4)
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1
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States, 10032
2
CUMC Research Pharmacy
New York, New York, United States, 10032
3
Szpital Specjalistyczny im. Sw. Rodziny SPZOZ
Warsaw, Poland, 02-544
4
Medical Concierge Centrum Medyczne
Warsaw, Poland, 02-798