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Clinical trial

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

NCT04165317 is registered in ClinicalTrials.gov with Pfizer as lead sponsor.

NCT NCT04165317
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Pfizer
Phase
Phase 3
Overall status
Active, not recruiting
Start date
December 30, 2019
Completion date
December 2, 2026
Enrollment
1,068 (actual)
Sites
194

Conditions

As the registry lists them; a condition with its own page is linked.

non-muscle invasive bladder cancer