Phase 2Recruiting
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients With Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)
- Sponsor
- National Cancer Institute (NCI) (NIH)
- Enrolment
- 180 planned
- Conditions
- Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Locally Recurrent Head and Neck Squamous Cell Carcinoma; Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma; Locally Recurrent Laryngeal Squamous Cell Carcinoma; Locally Recurrent Oral Cavity Squamous Cell Carcinoma; Locally Recurrent Oropharyngeal Squamous Cell Carcinoma; Stage II Laryngeal Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8
- Interventions
- Biospecimen Collection; Carboplatin; Cemiplimab; Cisplatin; Computed Tomography; Paclitaxel; Positron Emission Tomography; Radiation Therapy; Salvage Surgery
- Ages
- adults, older adults
- Registry
- NCT07195734
From the registry
This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery…
Primary outcomes
- Event free survival (EFS)