Study of Nivolumab in Combination with Ipilimumab compare to nivolumab in combination with Ipilimumab-Placebo in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)MedDRA version: 20.0Level: PTClassification code 10063569Term: Metastatic squamous cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001645-64-CZ
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 675
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 and HPV (oropharynx only) Performance status (ECOG 0-1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 473
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 202
Previous treatment of 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 virus
Previous treatment with checkpoint inhibitor drugs
Active CNS metastases or carcinomatous meningitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method