Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
This study tests whether adding chemotherapy drugs (carboplatin and paclitaxel) or a combination of chemotherapy plus an immunotherapy drug (cemiplimab) before surgery helps patients with advanced HPV-positive throat cancer live longer and with better outcomes. All patients will receive surgery followed by radiation and chemotherapy, but some will receive additional treatment beforehand to see if it improves results.
Key Objective: The trial is testing whether adding chemotherapy or chemo-immunotherapy before surgery improves survival and reduces cancer recurrence in patients with advanced HPV-positive oropharyngeal cancer.
Who to Consider: Patients with clinical stage II HPV-positive (p16-positive) oropharyngeal cancer who are candidates for surgery and willing to receive additional chemotherapy or immunotherapy treatment should consider enrolling.
Trial Parameters
Brief 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.
Eligibility Criteria
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 hypopharynx (American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual, 8th Edition) AND are deemed candidates for salvage surgery: * P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible. * Patients must be deemed surgically resectable without gross residual disease. * For patients with oral cavity SCCHN,