ImmunoModulation by the Combination of Ipilimumab and nivolumab neoadjuvant to Surgery In advanced Or recurrent Head and Neck Carcinoma, (IMCISION), a phase-Ib/II trial. Subtitle: Hypoxia as a determinant for the effect of nivolumab with or without ipilimumab on intra-tumoral T cell capacity
Completed
- Conditions
- head and neck squamous cell carcinoma10038666
- Registration Number
- NL-OMON42832
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
1. No immunosuppressive medications prior study inclusion, adults age > 18 years, and
2. Histologically confirmed T3-4N0-3M0 HNSCC (with soft tissue infiltration depth of * 1 cm) of the oral cavity, oropharynx, hypopharynx or supraglottic larynx, eligible for curative surgery as primary treatment or salvage surgery after failed (chemo)radiation.
3. WHO 0-1
Exclusion Criteria
- Distant metastasis
- Autoimmune disease
- A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration.
- Prior systemic treatment with immunotherapy targeting T-cell costimulation or immune checkpoint pathways;
- Hepatitis B / C, HIV or (AIDS);
- Pregnant or nursing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method