PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Withdrawn before enrolling · Phase 1
Conditions studied: Bladder Cancer
In brief
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 participants with recurrent non-muscle invasive bladder cancer. This study consists of 2 parts, single agent dose escalation (Part 1A), dose finding of PF-07225570 in combination with anti-PD-1 antibody (Part 1B) and dose expansion (Part 2).
Key facts
- Study ID
- NCT05259397
- Run by
- Pfizer
- People needed
- 0
- Starts
- 2022-03-24
- Expected to finish
- 2022-09-19
- Last updated by the study team
- 2023-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States
- CUMC Research Pharmacy — New York, New York, United States
- Szpital Specjalistyczny im. Sw. Rodziny SPZOZ — Warsaw, Poland
- Medical Concierge Centrum Medyczne — Warsaw, Poland
Full record on ClinicalTrials.gov
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