Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Not Recruiting

Trial ID: NCT02741570


The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

Official 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 (SCCHN)

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


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.

   - No prior systemic cancer therapy for recurrent or metastatic disease (except if
   chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).

   - 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 (eg. mucosal melanoma).

   - No 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.

   - 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


biological: Nivolumab

biological: Ipilimumab

drug: Cetuximab/Erbitux

drug: Cisplatin/Platinol

drug: Carboplatin/Paraplatin

drug: Fluorouracil/Adrucil

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

New Trial Alerts