Clinical Trial 18839

Cancer Type: Head & Neck
Interventions:BMS-936558 (Nivolumab); Ipilimumab; Nivolumab; Placebo; Yervoy (Ipilimumab)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Christine Chung

Overview

Study Title

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)

Summary

The purpose of this study is to compare the effectiveness (how well the drug works), safety, and tolerability of the combination of two investigational drugs called nivolumab and ipilimumab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have not had prior systematic chemotherapy. Nivolumab and ipilimumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. Nivolumab (Opdivo) has been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers. Ipilimumab (Yervoy) is approved by the FDA, EMA and other health authorities for the treatment of metastatic melanoma.

Objective

To compare the objective response rate (ORR) of the treatment of nivolumab in combination with ipilumumab vs monotherapy with nivolumab, as determined by a blinded independent radiology committee (BIRC) in patients with SCCHN relapse less than 6 months after platinum-based chemotherapy (platinum refractory) for locally advanced disease (LAD), adjuvant or neo-adjuvant setting, as first line treatment in subjects with recurrent or metastatic SCCHN.

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)
  • 18 years of age or older

  • 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 central nervous system (CNS) metastases or carcinomatous meningitis
  • Other protocol defined inclusion/exclusion criteria could apply