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

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

INTRODUCTION

  • Org Study ID: C4661001
  • Secondary ID: 2021-005858-28
  • NTC ID: NCT05259397
  • Sponsor: Pfizer
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BRIEF 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).

  • Overall Status
    Recruiting
  • Start Date
    March 24, 2022
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with Dose limiting toxicities

Primary Outcome 1 - Timeframe: Baseline up to 28 days

Primary Outcome 2 - Measure: Number of Participants with Adverse Events (AEs) according to Severity

Primary Outcome 2 - Timeframe: Baseline up to approximately 24 months

Primary Outcome 3 - Measure: Number of Participants with AEs according to Seriousness

Primary Outcome 3 - Timeframe: Baseline up to approximately 24 months

Primary Outcome 4 - Measure: Number of Participants with AEs according to Relationship

Primary Outcome 4 - Timeframe: Baseline up to approximately 24 months

CONDITION

  • Bladder Cancer

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Pfizer CT.gov Call Center

Role: Study Director

Affiliation: Pfizer

Overall Contact

Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

LOCATION

Facility Status Contact
Facility: Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
United States
Status: Recruiting Contact: N/A
Facility: CUMC Research Pharmacy
New York, New York 10032
United States
Status: Recruiting Contact: N/A