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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT06211335
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Losartan — DRUG
    Given PO
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Dec 7, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (losartan, SBRT, pembrolizumab)
    Patients receive losartan PO 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 IV and repeat every 3 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo PET, tumor biopsy, and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of treatment related adverse events [ Time Frame: Up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Shyam S.D. Rao, MD, PhD
[email protected]
916-734-5810
Shyam S. Rao, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Colorado Denver | Anschutz Medical CampusAuroraColorado80045
Alice N Weaver, MD, PhD
[email protected]
720-848-3532
Alice N Weaver, MD, PhD (PRINCIPAL_INVESTIGATOR)

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