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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and overCA209-651
NCI-2016-01450, 2016-000725-39, NCT02741570

Trial Description

Summary

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

Eligibility Criteria

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

disorder.

Inadequate hematologic, renal or hepatic function.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Bristol-Myers Squibb

    Trial Sites

    U.S.A.

    California
    Duarte

    City of Hope Comprehensive Cancer Center

    Erminia Massarelli
    Principal Investigator

    Palo Alto

    Stanford Cancer Institute

    Alexander Dimitrios Colevas
    Principal Investigator

    Florida
    Tampa

    Moffitt Cancer Center

    Jeffery Scott Russell
    Principal Investigator

    Georgia
    Atlanta

    Emory University/Winship Cancer Institute

    Nabil F. Saba
    Principal Investigator

    Nabil F. Saba
    Principal Investigator

    Illinois
    Chicago

    University of Chicago Comprehensive Cancer Center

    Everett E. Vokes
    Principal Investigator

    Massachusetts
    Boston

    Brigham and Women's Hospital

    Robert I. Haddad
    Principal Investigator

    Dana-Farber Cancer Institute

    Robert I. Haddad
    Principal Investigator

    Michigan
    Ann Arbor

    University of Michigan Comprehensive Cancer Center

    Francis Paul Worden
    Principal Investigator

    Ohio
    Columbus

    Ohio State University Comprehensive Cancer Center

    Maura Lianne Gillison
    Principal Investigator

    Virginia
    Charlottesville

    University of Virginia Cancer Center

    Elizabeth M. Gaughan
    Principal Investigator

    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.