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

Pfizer

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Bladder Cancer

Interventions

PF-07225570DRUG

PF-07225570 given IVe in a 28-day cycle (as induction and maintenance regimen). Multiple dose levels will be evaluated.

sasanlimabDRUG

Sasanlimab will be administered SQ on day 1 of each 28 day cycle.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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 Criteria: 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

Locations (4)

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

Outcomes

Primary Outcomes

Number of participants with Dose limiting toxicities

Time frame: Baseline up to 28 days

Number of Participants with Adverse Events (AEs) according to Severity

Time frame: Baseline up to approximately 24 months

Number of Participants with AEs according to Seriousness

Time frame: Baseline up to approximately 24 months

Number of Participants with AEs according to Relationship

Time frame: Baseline up to approximately 24 months

Secondary Outcomes

Proportion of participants with carcinoma in situ (CIS) achieving complete response at any time after first dose of PF 07225570

Time frame: Baseline up to 24 months

Durability of complete responses (CRs) as measured from time of documented CR to time of high-grade tumor recurrence, disease progression, or death (whichever occurs first) in participants who achieved a CR

Time frame: Baseline up to 24 months

For participants with high-grade Ta/ T1 disease only, Proportion of participants without high-grade-recurrence at each assessment visit.

Ta is defined as the stage of bladder cancer as a non-invasive papillary carcinoma. T1 is defined as the stage of cancer in which the cancer cells are only growing in the most superficial layer of tissues and have not grown into deeper tissues; in bladder cancer, T1 is defined as an invasion into the lamina propria without invasion into the muscularis propria

Time frame: Baseline up to 24 months

Maximum Observed Plasma Concentration (Cmax) of PF-7225570 after a single dose

Data from ClinicalTrials.gov

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