Bladder Cancer Clinical Trial
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
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).
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
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
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