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)
National Cancer Institute (NCI)
Summary
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 that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.
Description
PRIMARY OBJECTIVE: I. To assess and compare investigator-assessed event-free survival (EFS) of patients treated with chemotherapy (carboplatin + paclitaxel) or chemo-immunotherapy (carboplatin + paclitaxel + cemiplimab \[REGN2810\]) prior to salvage surgery (SS) versus patients undergoing standard of care SS. SECONDARY OBJECTIVES: I. To assess and compare disease-free survival (DFS). II. To assess and compare overall survival (OS). III. To assess and compare distant metastasis (DM). IV. To assess and compare acute and late toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] v…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx * PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory * Verify insurance (or other payment) coverage for neoadjuvant chemotherapy * Measurable disease as defined by RECIST 1.1 * Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hyp…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugCarboplatin
Given IV
- BiologicalCemiplimab
Given IV
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- DrugPaclitaxel
Given IV
- ProcedurePositron Emission Tomography
Undergo PET scan
Locations (40)
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- Sutter Medical Center SacramentoSacramento, California
- Emory Proton Therapy CenterAtlanta, Georgia
- Emory University Hospital MidtownAtlanta, Georgia
- Rush MD Anderson Cancer CenterChicago, Illinois
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, Iowa