NCT06211335

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

Phase Ib Study of Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy (SBRT) in Patients With Locoregionally Recurrent, Refractory, or Oligometastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial tests the safety, side effects and how well losartan, pembrolizumab and stereotactic body radiation therapy (SBRT) for the treatment of patients with head and neck squamous cell carcinoma that has come back to nearby tissue or lymph node after a period of improvement (locally recurrent), that has not responded to previous treatment (refractory) or that has spread from where it first started to multiple other placed in the body (oligometastatic). Losartan is a drug used to treat high blood pressure that may enhance the effects of other cancer treatments such as immunotherapy and radiation. Immunotherapy with pembrolizumab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving losartan, pembrolizumab and SBRT may work better in treating patients with locally recurrent, refractory or oligometastatic head and neck squamous cell carcinoma.

Detailed description

PRIMARY OBJECTIVE:I. Determine the safety and toxicity of losartan in combination with SBRT and subsequently pembrolizumab in patients with locally recurrent, refractory, or oligometastatic head and neck squamous cell carcinoma (HNSCC). SECONDARY OBJECTIVES:I. Evaluate objective tumor response.II. Evaluate progression free survival (PFS). III. Evaluate duration of response.IV. Evaluate overall survival (OS). OUTLINE:Patients receive losartan orally (PO) once daily (QD). One week later patients receive SBRT 2-3 times per week for approximately 2 weeks. Within 1 week of completing SBRT, patients receive pembrolizumab intravenously (IV) and repeat every 3 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET), tumor biopsy, and blood sample collection throughout the study.After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year.

Conditions

• Locally Recurrent Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Refractory Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Losartan	Given PO
BIOLOGICAL	Pembrolizumab	Given IV
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2023-12-07
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-01-18
• Last updated: 2026-03-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study