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
Basic Trial Information
|Phase III||Treatment||Active||18 and over||CA209-651|
NCI-2016-01450, 2016-000725-39, NCT02741570
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
Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to
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.
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 disorder.
Inadequate hematologic, renal or hepatic function.
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
The University of Arizona Medical Center-University Campus
Julie E. Bauman
City of Hope Comprehensive Cancer Center
Stanford Cancer Institute Palo Alto
Alexander Dimitrios Colevas
Moffitt Cancer Center
Jeffery Scott Russell
Emory University/Winship Cancer Institute
Nabil F. Saba
University of Chicago Comprehensive Cancer Center
Everett E. Vokes
Brigham and Women's Hospital
Robert I. Haddad
Dana-Farber Cancer Institute
Robert I. Haddad
University of Michigan Comprehensive Cancer Center
Francis Paul Worden
Ohio State University Comprehensive Cancer Center
Maura Lianne Gillison
University of Virginia Cancer Center
Elizabeth M. Gaughan
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02741570
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.