Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-16134

Full 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)


The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study

regimen as first line treatment in patients with recurrent or metastatic squamous cell of

the head and neck cancer

Are you eligible?

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.

Patients with certain diseases such as active autoimmune disease, type I diabetes,

hypothyroidism that needs hormone replacement, active infection, psychiatric


Inadequate hematologic, renal or hepatic function.

Head & Neck Cancers