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: 21.0Level: 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-AT
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1329
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 930
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 399
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 PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation 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 the OS of participants with PD-L1 expressing tumors who are receiving nivolumab combined with ipilimumab to those receiving EXTREME regimen.<br><br>To compare the OS of all study participants receiving nivolumab combined with ipilimumab to those receiving EXTREME regimen;Secondary Objective: To compare the OS of participants with PD-L1 expressing tumors who are receiving nivolumab combined with ipilimumab to those receiving EXTREME regimen<br><br>To evaluate progression-free survival (PFS), objective response rate (ORR) and the duration of response (DOR), based on BICR in all study participants and those with PD-L1 expressing tumors who are receiving nivolumab combined with ipilimumab, and those receiving EXTREME regimen.;Primary end point(s): Overall Survival (OS) in randomized participants with PD-L1 expressing tumors;Timepoint(s) of evaluation of this end point: 51 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): OS in randomized participants with PD-L1 expressing tumors <br><br>PFS in all participants<br><br>Objective Response Rate (ORR) in all participants <br><br>Duration of Response (DOR) in all participants<br><br><br><br><br>;Timepoint(s) of evaluation of this end point: Approximately 32 months