RecruitingPhase 1NCT06211335

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)


Sponsor

University of California, Davis

Enrollment

24 participants

Start Date

Dec 7, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments — losartan (a blood pressure medication), pembrolizumab (an immunotherapy drug), and targeted radiation — for people with head and neck squamous cell carcinoma (a type of cancer in the mouth, throat, or neck area) that has come back, stopped responding to treatment, or spread to a small number of other sites. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the head and neck that has returned, is not responding to current treatment, or has spread to no more than 4 spots - Your cancer cannot be fully removed with surgery - You are 18 or older and in reasonably good physical health (able to carry out daily activities) - You have measurable cancer that can be seen on a CT or MRI scan - Your blood counts, liver, and kidney function are within acceptable ranges - You are willing to use contraception during the study and for up to 3 months after **You may NOT be eligible if...** - Your cancer started in the nasopharynx, salivary gland, or skin - You have previously been treated with a checkpoint immunotherapy drug (like nivolumab, atezolizumab, or similar) - You have significant heart, lung, or nerve problems unrelated to your cancer - You have had radiation to the head and neck in the past 6 months - You are currently taking blood pressure medications that work on the same pathway as losartan (ACE inhibitors or ARBs) - You have uncontrolled diabetes or active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLosartan

Given PO

BIOLOGICALPembrolizumab

Given IV

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT


Locations(2)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States

View Full Details on ClinicalTrials.gov

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NCT06211335


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