Clinical Trials Search
Clinical Trial 18838
Interventions:5-fluorouracil; BMS-936558 (Nivolumab); Cetuximab; Erbitux (Cetuximab); Ipilimumab; Nivolumab; Paraplatin (carboplatin); Yervoy (Ipilimumab); carboplatin; cisplatin
Study Type: Treatment
Phase of Study: Phase III
- Christine Chung
An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the combination of two investigational drugs called nivolumab and ipilimumab. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab (Opdivo) has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers. Ipilimumab (Yervoy) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma.
Primary Objective: To compare progression free survival (PFS) as determined by independent radiology committee (IRC), and overall survival (OS) of Nivolumab combined with Ipilimumab to Extreme regimen as first line treatment in subjects with recurrent or metastatic SCCHN.