Trial of Nivolumab vs Therapy of Investigator’s Choice in Recurrent or Metastatic Head and Neck Carcinoma
- Conditions
- Squamous cell carcinoma of the head and neckMedDRA version: 20.0 Level: PT Classification code 10066471 Term: Squamous cell carcinoma of pharynx System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10023856 Term: Laryngeal squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003622-86-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
- Men and women = 18 years of age with an ECOG performance status = 1.
- Histologically confirmed recurrent or metastatic HNSCC (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
- Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting.
- Measurable disease by CT or MRI per RECIST 1.1 criteria.
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
- Active brain metastases or leptomeningeal metastases are not allowed.
- Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or nonsquamous histologies (eg mucosal melanoma) are not allowed
- Subjects with active, known or suspected autoimmune disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to find out whether nivolumab will significantly improve overall survival as compared to therapy of investigator’s choice in patients with recurrent or metastatic head and neck carcinoma.;<br> Secondary Objective: -Progression free survival (PFS)<br> -Objective Response Rate<br> ;Primary end point(s): Overall Survival (OS);<br> Timepoint(s) of evaluation of this end point: For OS: Every 3 months during the survival follow-up phase<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. Progression free survival (PFS)<br> 2. Objective Response Rate (ORR)<br> ;<br> Timepoint(s) of evaluation of this end point: Starting at week 9 and then every 6 weeks after randomization, until disease progression or study drug is discontinued (whichever occurs later).<br> For PFS, starting at Week 9 and then every 6 weeks after randomization, until disease progression<br>