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

Bladder Cancer Clinical Trial

Official title:

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05259397
• Other study ID #: C4661001
• Secondary ID: 2021-005858-28
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 24, 2022
• Est. completion date: September 19, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• PF-07225570
PF-07225570 given IVe in a 28-day cycle (as induction and maintenance regimen). Multiple dose levels will be evaluated.
• sasanlimab
Sasanlimab will be administered SQ on day 1 of each 28 day cycle.

Locations

Country	Name	City	State
Poland	Medical Concierge Centrum Medyczne	Warszawa
Poland	Szpital Specjalistyczny im. Sw. Rodziny SPZOZ	Warszawa
United States	Columbia University Medical Center - Herbert Irving Pavilion	New York	New York
United States	CUMC Research Pharmacy	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Dose limiting toxicities		Baseline up to 28 days
Primary	Number of Participants with Adverse Events (AEs) according to Severity		Baseline up to approximately 24 months
Primary	Number of Participants with AEs according to Seriousness		Baseline up to approximately 24 months
Primary	Number of Participants with AEs according to Relationship		Baseline up to approximately 24 months
Secondary	Proportion of participants with carcinoma in situ (CIS) achieving complete response at any time after first dose of PF 07225570		Baseline up to 24 months
Secondary	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		Baseline up to 24 months
Secondary	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	Baseline up to 24 months
Secondary	Maximum Observed Plasma Concentration (Cmax) of PF-7225570 after a single dose		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07225570 after a single dose		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07225570 after a single dose		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0.5, 1, 2, 3, 4, 6 and 24 hours after instillation
Secondary	Concentration from maximum to steady state (Cmax,ss) of PF-07225570 after multiple doses		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation
Secondary	Time from maximum concentration to steady state (Tmax,ss) of PF-07225570 after multiple doses		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation
Secondary	Area under the curve from specified time to steady state (AUCt,ss) of PF-07225570 after multiple doses		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 2 hours after instillation
Secondary	Urine PF-07225570 concentration after a single dose		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours, and 4 - 6 hours post-instillation on Cycle 1 Day 1
Secondary	Urine PF-07225570 concentration after multiple doses		Pre-dose on Cycle 1 (each cycle is 28 days) Day 1 and at 0-2 hours and 2 - 4 hours post-instillation.
Secondary	Progression-Free Survival		Baseline up to 24 months
Secondary	Incidence of Radical Cystectomy		Baseline up to 24 months
Secondary	Overall survival		Baseline up to 3 years
Secondary	Serum sasanlimab concentrations		Pre-dose (within 6 hours) before each administration
Secondary	Incidence and titers of neutralizing antibodies (NAb) against sasanlimab		Pre-dose (within 6 hours) before each administration
Secondary	Incidence and titers of anti-drug antibodies (ADA) against sasanlimab		Pre-dose (within 6 hours) before each administration

External Links

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