A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination with Ipilimumab versus Nivolumab in combination with Ipilimumab placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 2
Completed
- Conditions
- eoplasms - Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerSCCHNSCCH
- Registration Number
- NL-OMON47328
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the Objective Response Rate (ORR) and Duration of Response (DoR) of<br /><br>the treatment of nivolumab in combination with ipilumumab vs. nivolumab in<br /><br>combination with ipilimumab placebo, as determined by a blinded independent<br /><br>central review (BICR) using RECIST 1.1 criteria, for first line treatment of<br /><br>recurrent or metastatic SCCHN in the platinum refractory setting.</p><br>
- Secondary Outcome Measures
Name Time Method