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A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

NCT04165317 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1068

Last updated 2026-01-22

Study results available
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Summary

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).

In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.

* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.

In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.

\- Both groups will be given sasanlimab at the study clinic.

On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

Conditions

Interventions

DRUG

PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.

DRUG

Bacillus Calmette-Guerin

Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2024-12-02
Completion
2026-12-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165317 on ClinicalTrials.gov