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
- Conditions
- Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)MedDRA version: 19.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000725-39-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 947
-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.
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 490
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210
- 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-PD-1, anti-PD-L1, anti-CTLA-4 antibody or any other antibody or drugs targeting T-cell co-stimulation 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression free survival (PFS) as determined by independent radiology committee (IRC), and overall survival (OS) of nivolumab combined with ipilimumab to Extreme regimen as first line treatment in subjects with recurrent or metastatic SCCHN.;Secondary Objective: -To compare the objective response rate (ORR), as determined by IRC<br>-To compare time to symptom deterioration (TTSD) as assessed using the 10-item Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) Symptom Index (FHNSI-10)<br>-To evaluate whether PD-L1 expression is a predictive biomarker for ORR, PFS and OS.;Primary end point(s): - Overall survival (OS) of nivolumab and ipilimumab versus Extreme regimen<br>-Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: - OS: approximately 36 months<br>- PFS: approximately 36 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Objective response rate (ORR)<br>- Assess meaningful worsening of symptoms<br>- Evaluate PD-L1 expression as a predictive biomarker for efficacy;Timepoint(s) of evaluation of this end point: - ORR: approximately 36 months<br>- worsening of symptoms: approximately 36 months<br>- PDL1 expression: approximately 36 months