Neoplasms - Squamous Cell Carcinoma of the Head and Neck Head and Neck Cancer SCCHN
Conditions
Interventions
Subjects will be randomly assigned to a treatment arm in a 2:1 ratio,
allocation will be double-blinded.
Arm A:
* Nivolumab 3 mg/kg IV will be administered every 2 weeks
* Ipilimumab 1 mg/kg IV wil
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Confirmed squamous cell head and neck cancer Widespread (metastatic) disease, or returned after previous treatment (recurrent) No previous treatment for metastatic or recurrent disease Tumor sample must be available for analysis of PDL1 and HPV (oropharynx only) Performance status (ECOG 0-1)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Objective Response Rate (ORR) and Duration of Response (DoR) of the treatment of nivolumab in combination with ipilumumab vs. nivolumab in combination with ipilimumab placebo, as determined by a blinded independent central review (BICR) using RECIST 1.1 criteria, for first line treatment of recurrent or metastatic SCCHN in the platinum refractory setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: - To compare the ORR and DoR of the treatment of nivolumab in combination with ipilimumab vs nivolumab in combination with ipilimumab placebo in the platinum eligible setting - To assess progression-free survival (PFS) and overall survival (OS) of nivolumab in combination with ipilimumab vs. nivolumab in combination with ipilimumab placebo in the platinum eligible and platinum refractory settings, separately and overall - To assess efficacy (ORR, PFS and OS) by PD-L1 expression and HPV p-16 status of nivolumab in combination with ipilumumab compared to nivolumab in combination with ipilimumab placebo in the platinum eligible and platinum refractory settings, separately and overall Exploratory Objectives - To assess the ORR, PFS and disease control rate (DCR) of the treatment of nivolumab in combination with ipilimumab vs nivolumab in combination with ipilimumab placebo, as determined by the investigator using RECIST 1.1 criteria in the platinum eligible and platinum refractory settings, separately and overall - To assess safety and tolerability nivolumab in combination with ipilimumab/ipilimumab placebo - To assess the subject's overall health status and health utility using the 3-level version of the EQ-5D (EQ-5D-3L) visual analog scale (VAS) and utility index, respectively - To assess the subject's cancer-related symptoms and quality of life using components of the Functional Assessment of Cancer Therapy Head and Neck (FACT-HN) cancer questionnaire - To evaluate differences in subject-reported symptomatic adverse events using selected items from the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - To investigate the immunomodulatory properties of nivolumab in combination with ipilimumab or with ipilimumab placebo, and to evaluate potential baseline and on-treatment biomarkers for association with efficacy - To characterize the pharmacokinetics and immunogenic | — |
Countries
Netherlands
Outcome results
None listed