Actively Recruiting
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
Led by University of California, Davis · Updated on 2026-03-12
24
Participants Needed
2
Research Sites
181 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locoregionally recurrent, refractory, or oligometastatic (up to 4 lesions) squamous cell carcinoma of the head and neck not suitable for curative surgery
- Known p16 status for cancers of the base of tongue, soft palate, and tonsil
- Tumor suitable for sequential biopsies and willingness to undergo these if considered safe by the doctor
- Prior radiation therapy to head and neck allowed with disease limited to up to 4 active sites or adjacent treatable sites with maximum tumor dimension less than 7.5 cm unless approved by the primary investigator
- Prior systemic therapy allowed; patients with locoregional relapses where radiation alone is indicated may enroll without prior systemic therapy
- Presence of measurable disease on CT or MRI scans according to RECIST 1.1
- Combined positive score (CPS) greater than 1%
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Leukocytes count at least 3 x 10^9/L
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Hemoglobin level at least 9 g/dL; transfusions allowed to reach this level without washout
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal
- AST and ALT less than or equal to 2.5 times institutional upper limit of normal
- Creatinine within normal limits or creatinine clearance at least 30 mL/min/1.73 m^2 if creatinine is elevated
- Use of effective contraception during study and for 3 months after for individuals of childbearing potential or with partners of childbearing potential, or surgical sterilization
- Ability to understand, sign informed consent, and willingness to follow study schedule and requirements
You will not qualify if you...
- Nasopharyngeal carcinoma, salivary gland carcinoma, or primary skin squamous cell carcinoma
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
- Chemotherapy or other anti-cancer treatment within 3 weeks before study start
- Allergy to losartan or any of its components
- Radiation therapy within 6 months before study start
- Disease involving more than 50% of the carotid artery
- Not recovered to grade 1 or less from previous cancer treatment side effects except hair loss
- Major surgery within 28 days before study start without full recovery
- Significant bleeding within 4 weeks before study start
- Active infection requiring intravenous antibiotics within 4 weeks before study start
- Uncontrolled or significant diabetes with hemoglobin A1C above 8.5%
- Active autoimmune disorders needing systemic treatment in past 2 years except well-managed or inactive disorders at investigator's discretion
- Current use of systemic corticosteroids over 10 mg prednisone equivalent per day
- Current use of angiotensin receptor blockers or ACE inhibitors for hypertension
- Significant other diseases that preclude losartan treatment as judged by investigator
- Other active cancers except certain low-risk or cured skin and prostate cancers
- Positive hepatitis C, hepatitis B, or HIV antibody tests unless viral loads are negative
- Live vaccines within 28 days before study start; inactivated flu vaccines allowed
- Prior use of losartan or other TGF-beta-directed therapies
- Use of other investigational drugs or therapies within 28 days or 5 times half-life prior to study start
- Pregnant or breastfeeding
- Any condition interfering with safety, compliance, or consent as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
2
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
O
Office of Clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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