A Phase 3 Randomized Open-Label Three Arm Study of PF-06801591 in Combination with BCG (Induction With or Without Maintenance) Versus BCG (Induction and Maintenance) in Participants with HR BCG-Na ve NMIBC (B8011006)

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A Phase 3 Randomized Open-Label Three Arm Study of PF-06801591 in Combination with BCG (Induction With or Without Maintenance) Versus BCG (Induction and Maintenance) in Participants with HR BCG-Na ve NMIBC (B8011006)

Brief description of study

The purpose of the study is to determine the safety and efficacy of PF-06801591 (an anti-PD-1 antibody) combined with Bacillus Calmette- Guerin (BCG) in patients with high-risk, BCG-naïve Non-Muscle Invasive Bladder Cancer (NMIBC). We want to know if the combined treatment of PF-06801591 and Bacillus Calmette- Guerin (BCG) works better than BCG alone.

Clinical Study Identifier: s19-01432

ClinicalTrials.gov Identifier: NCT04165317

Principal Investigator: Gary D. Steinberg.

Other Investigators: Mohit Gupta, James S Wysock, David R. Wise, William C Huang, Victor Ricardo Adorno Febles.

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Perlmutter Cancer Center

Clinical Trials & Research Studies