Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

  • Interventional
  • Not Recruiting
  • NCT02823574
Eligibility Details Visit Clinicaltrials.gov

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

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:

         - Confirmed squamous cell head and neck cancer

         - Widespread (metastatic) disease, or returned after previous treatment (recurrent)

         - Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]

         - Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

        Exclusion Criteria:

         - Previous treatment for metastatic or recurrent disease

         - Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin

         - Any non-squamous subtype

         - Active autoimmune disease

         - Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus

         - Previous treatment with checkpoint inhibitor drugs

         - Active CNS metastases or carcinomatous meningitis

        Other protocol defined inclusion/exclusion criteria could apply

At a Glance

National Government IDNCT02823574

IRB#IRB16-1678

Lead SponsorBristol-Myers Squibb

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting