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Clinical Trial 18838

Cancer Type:
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

Call 813-745-6100
or 1-800-679-0775

Study Title

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.

Inclusion Criteria

  • Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy. .> Measurable disease detected by imaging exam (CT or MRI).
  • Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.

  • Exclusion Criteria

  • Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non-squamous histologies (e.g., mucosal melanoma).
  • No prior treatment with systemic anti-cancer therapy for SCCHN, unless under all of the following conditions: (a) Prior chemotherapy was given as adjuvant or neoadjuvant chemotherapy, or part of multimodal (chemo, radiation) treatment for locally advanced disease (b) These treatments must have been completed > 6 months prior to enrollment (c) There is no evidence of disease progression for at least 6 months after completion of systemic treatment.
  • Prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
  • Potential participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
  • Inadequate hematologic, renal or hepatic function.
  • Other protocol defined inclusion/exclusion criteria could apply.