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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-24

Study Completion Date

2022-09-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A PF-07225570 monotherapy

Intravesical (IVe) Single Agent Dose Escalation

Group Type EXPERIMENTAL

PF-07225570

Intervention Type DRUG

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

Part 1B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab Subcutaneous (SQ) Combination Dose Escalation

Group Type EXPERIMENTAL

PF-07225570

Intervention Type DRUG

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

sasanlimab

Intervention Type DRUG

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

Part 2A PF-07225570 monotherapy

IVe Single Agent Dose Expansion

Group Type EXPERIMENTAL

PF-07225570

Intervention Type DRUG

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

Part 2B PF-07225570 and sasanlimab

PF-07225570 IVe and sasanlimab SQ Combination Dose Expansion

Group Type EXPERIMENTAL

PF-07225570

Intervention Type DRUG

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

sasanlimab

Intervention Type DRUG

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

Interventions

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PF-07225570

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

Intervention Type DRUG

sasanlimab

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

Intervention Type DRUG

Other Intervention Names

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anti-PD-1 (programmed cell death protein-1) antibody

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No