A Phase II Study of Volrustomig, Paclitaxel, and Carboplatin Followed by Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
University of Chicago
Summary
The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma .
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have pathologically confirmed locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses. * If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry (defined as negative immunohistochemical staining of p16) * Non-oropharyngeal primary sites do not require immunohistochemical or other means of testing for HPV status, however if they are performed, must be negative for HPV. * Nasopharyngeal primary must have bo…
Interventions
- DrugVolrustomig
500mg or 750mg (cycles 1-2) and 250mg thereafter IV day 1.
- DrugCarboplatin
100mg/m2 IV day 1 and day 8.
- DrugPaclitaxel
AUC 5 IV day 1
Location
- The University of ChicagoChicago, Illinois