NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN
Status:
Completed
Trial end date:
2020-03-26
Target enrollment:
Participant gender:
Summary
Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute
IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression
of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to
better evaluate the safety profile of nivolumab in a large series of patients with Recurrent
or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of
this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher),
treatment-related, select adverse events.