B8011006 - A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509089-39-00

Acronym

B8011006

Enrollment

313

Registered

2024-06-12

Start date

2020-07-01

Completion date

Unknown

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Muscle Invasive Bladder Cancer

Brief summary

Cohort A: EFS as assessed by the investigator., Cohorts B1 and B2: CR as assessed by the BICR. EFS as determined by the investigator

Detailed description

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohort A: EFS as assessed by the investigator., Cohorts B1 and B2: CR as assessed by the BICR. EFS as determined by the investigator	—

Secondary

Measure	Time frame
OS	—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results