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)

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 180 participants

Interventions

• PROCEDURE: Biospecimen Collection — Undergo blood sample collection
• DRUG: Carboplatin — Given IV
• BIOLOGICAL: Cemiplimab — Given IV
• DRUG: Cisplatin — Given IV
• PROCEDURE: Computed Tomography — Undergo CT scan

Primary Outcomes

• Event free survival (EFS) (From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years)

Secondary Outcomes

• Disease free survival (DFS) (From randomization until disease recurrence, death due to any cause, up to 7 years)
• Overall survival (OS) (From randomization until death due to any cause, up to 7 years)
• Time to distant metastasis (From randomization until detection of distant metastases or death, up to 7 years)
• Surgical complications (Up to 7 years)
• Incidence of acute adverse events (Up to 30 days from the last treatment)

Trial Locations

• Sutter Medical Center Sacramento, Sacramento, California, United States
• Methodist Jennie Edmundson Hospital, Council Bluffs, Iowa, United States
• University of Kansas Cancer Center, Kansas City, Kansas, United States
• University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
• University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
• LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States
• Our Lady of the Lake Physician Group, Baton Rouge, Louisiana, United States
• University of Kansas Cancer Center - Briarcliff, Kansas City, Missouri, United States
• University of Kansas Cancer Center - North, Kansas City, Missouri, United States
• University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
• ...and 9 more locations

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