A Phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Brief description of study
We want to know the safety and tolerability of the anti-programmed death 1 (PD-1) antibody nivolumab at different dose levels for patients with autoimmune disorders and advanced malignancies at varying severity that previously had not been eligible for nivolumab. The purpose of the study is to investigate nivolumab at the Food and Drug Administration (FDA)-approved dose of 480 mg intravenous (IV) every 4 weeks until unacceptable toxicity, disease progression, or completion of 2 years of therapy. The study drug nivolumab is investigational, but the FDA has given its permission to test this agent in the current trial.
Clinical Study Identifier: s19-01544
ClinicalTrials.gov Identifier: NCT03816345
Principal Investigator:
Janice Mehnert.
Other Investigators:
Nila Theresa De La Rosa,
Elaine Shum,
Sujata P. Thawani,
Amanda Marie Talmadge,
Scot Niglio,
Nitish Mehta,
Eva Chalas-Westermann,
Eneil De La Pena,
Maya Dimitrova,
Laura Palazzolo,
Jeffrey S. Weber,
Robert Steven Weiner,
Jonathan B Kahn,
Monica Rivera,
Fabia Brisard Pierrot,
Keriann M Scavone,
Marissa Rybstein,
Joshua K Sabari,
Nina Beri,
Jordan E Axelrad,
Caitlin Elizabeth Ryan,
David R. Wise,
Nina D'Abreo,
Jennifer Wu,
Salman Rafi Punekar,
Carol M Lee,
Cesar Erasmo Fors Nieves,
Jeffrey G Schneider,
Anastasiya Apanasyuk,
Samantha VanMaanen,
Kelly A Levine,
Edward A Jimenez,
Kristen Spencer,
Michael E Garrison,
Kathleen M Madden,
Michael Shusterman,
Douglas K Marks,
Alexander A Hindenburg.
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