drugset / Trial / NCT05721755

Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT05721755 ↗

RandomizedSequentialOpen-labelTreatment

Summary

This phase III trial compares pembrolizumab with radiation therapy to pembrolizumab without radiation therapy (standard therapy) given after pembrolizumab plus chemotherapy for the treatment of patients with squamous cell carcinoma of the head and neck that has spread from where it first started (primary site) to other places in the body (metastatic). Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Radiation therapy uses high-powered rays to kill cancer cells. Giving radiation with pembrolizumab may be more effective at treating patients with metastatic head and neck cancer than the standard therapy of giving pembrolizumab alone.

Timeline

Start
2023-06-08
Primary completion
2029-03-31
Completion
2030-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cisplatin Other / unclassified — Intravenous
Background Paclitaxel Small molecule — Intravenous
Background fluorouracil Small molecule — Intravenous