Title: Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity1
Principal Investigator: Jonathan Schoenfeld, MD, Dana-Farber Cancer Institute, Boston, Massachusetts
Description: The open-label, phase 2 trial (ClinicalTrials.gov Identifier: NCT02919683) is recruiting participants with squamous cell carcinoma of the oral cavity to evaluate the activity and safety of neoadjuvant nivolumab with or without ipilimumab.
The study is randomly assigning adult patients eligible to undergo surgery to receive 2 weeks of intravenous nivolumab plus 1 week of intravenous ipilimumab or nivolumab alone prior to undergoing a standard of care operation for resection of the primary tumor.
The primary endpoint is overall response rate at the time of surgery. Investigators will also assess pathologic response and the number of participants with treatment-related adverse events at the time of surgery, as well as local and regional failure rates, local and regional progression-free survival, disease-free survival, and overall survival at 2 years.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02919683.
Status: This study is recruiting patients as of February 9, 2017.
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody approved by the U.S. Food and Drug Administration as a single agent for the treatment of advanced non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, and squamous cell carcinoma of the head and neck.
Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of advanced melanoma and the adjuvant treatment of cutaneous melanoma with regional lymph node involvement.
- ClinicalTrials.gov. Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity. NCT02919683. https://clinicaltrials.gov/ct2/show/NCT02919683. Accessed February 9, 2017.