A Phase II Randomized Trial of Adjuvant Therapy with Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma with High Risk Features
This phase II trial studies the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin and carboplatin kill tumor cells by stopping them from dividing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab in combination with radiation therapy or pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Primary Objectives * To evaluate OS of adjuvant reirradiation plus concurrent pembrolizumab followed by pembrolizumab to complete 12 months total of pembrolizumab to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients. * To evaluate OS of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk HNSCC patients. Secondary Objectives * To evaluate the following endpoints in all arms: DFS, Locoregional control, Rates of distant metastasis, Toxicity. * To evaluate whether high PD-L1 expression (defined as CPS ¡Ý 20) is predictive of increased efficacy in the experimental groups compared to control.
Chemotherapy (NOS); Radiotherapy; Therapy (NOS)
Paraplatin (carboplatin); Pembrolizumab (Keytruda); Radiotherapy (); carboplatin (); cisplatin ()
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