A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
University of Chicago
Summary
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Newly diagnosed, pathologically proven, treatment-naïve unresected LA-HNSCC * Stage T3-T4 \[N0-N3\] or any N2a-3 \[T1-T4\] larynx, hypopharynx, oral cavity, or p16(-) oropharynx (AJCC 8th edition staging) * Stage T4 or N3 p16(+) oropharynx (AJCC 8th edition staging) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers b…
Interventions
- DrugCemiplimab
350 mg via IV
- DrugFianlimab
1600 mg via IV
- DrugCarboplatin
Target AUC 5 via IV
- DrugPaclitaxel
100 mg/m2 via IV
- RadiationRadiation
Radiotherapy will be delivered to a total dose of 70 Gy.
Location
- The University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois