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)
University of California, Davis
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.
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, patien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed locoregionally recurrent, refractory, or oligometastatic (at most 4 lesions) squamous cell carcinoma of the head and neck not amenable to curative resection * p16 status known for base of tongue, soft palate, and tonsil cancers * Tumor amenable to sequential biopsies, and patients willing to undergo sequential tumor biopsies so long as the treating investigator considers them to be clinically safe * Prior radiotherapy to the head and neck is allowed. Disease should be limited to up to 4 sites of active disease in the head and nec…
Interventions
- DrugLosartan
Given PO
- BiologicalPembrolizumab
Given IV
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
Locations (2)
- University of California Davis Comprehensive Cancer CenterSacramento, California
- University of Colorado Denver | Anschutz Medical CampusAurora, Colorado