Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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 criteria
Qualifiers
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 both EBV and HPV ruled out by immunohistochemistry to be eligible.
Disqualifiers
Unequivocal demonstration of distant metastatic disease (M1 disease).
Unidentifiable primary site.
Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
Patients who are receiving any other investigational agents.
Trial design
Treatments tested in this trial
- Volrustomig
- Carboplatin
- Paclitaxel
Treatment groups
38 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov