Phase 1b Study of Losartan, Pembrolizumab, and Stereotactic Body Radiation Therapy for Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety, side effects, and effectiveness of combining losartan, pembrolizumab, and stereotactic body radiation therapy SBRT for patients with head and neck squamous cell carcinoma that has returned locally, resisted prior treatments, or spread to a few other body sites. This phase Ib trial focuses on how these treatments may work together to better control this type of cancer by affecting tumor growth and the immune system. Participants take losartan by mouth daily, starting one week before SBRT, which delivers precise radiation 2-3 times weekly for about two weeks. Then, pembrolizumab is given intravenously within a week after completing SBRT and repeated every three weeks. Treatment lasts up to one year if the disease does not worsen or side effects become unacceptable. Throughout the study, patients undergo PET scans, tumor biopsies, and blood tests to monitor progress. Patients are followed for safety and disease status for up to two years after treatment begins, with assessments including tumor response, progression-free survival, and overall survival. Follow-up visits occur 30 days post-treatment and every three months for one year. The study measures treatment-related adverse events and evaluates how well the combination controls cancer over time while tracking patient health and side effects.

Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma