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

  • Interventional
  • Recruiting
  • NCT02741570
Eligibility Details Visit Clinicaltrials.gov

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

        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.

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT02741570

IRB#IRB16-0680

Lead SponsorBristol-Myers Squibb

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting