Actively Recruiting
Phase Ib Study of Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy in Patients With Locoregionally 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
26 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
Researchers are evaluating the safety, side effects, and effectiveness of combining losartan, pembrolizumab, and stereotactic body radiation therapy (SBRT) for patients with head and neck squamous cell carcinoma that has returned locally, resisted prior treatments, or spread to a few other body sites. This phase Ib trial focuses on how these treatments may work together to better control this type of cancer by affecting tumor growth and the immune system. Participants take losartan by mouth daily, starting one week before SBRT, which delivers precise radiation 2-3 times weekly for about two weeks. Then, pembrolizumab is given intravenously within a week after completing SBRT and repeated every three weeks. Treatment lasts up to one year if the disease does not worsen or side effects become unacceptable. Throughout the study, patients undergo PET scans, tumor biopsies, and blood tests to monitor progress. Patients are followed for safety and disease status for up to two years after treatment begins, with assessments including tumor response, progression-free survival, and overall survival. Follow-up visits occur 30 days post-treatment and every three months for one year. The study measures treatment-related adverse events and evaluates how well the combination controls cancer over time while tracking patient health and side effects.
CONDITIONS
Brief 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 willing to undergo biopsies if safe
- Prior head and neck radiotherapy allowed with disease limited to up to 4 sites treatable safely
- Prior systemic therapy allowed; patients with locoregional relapse may enroll without prior systemic therapy
- Measurable disease by RECIST 1.1 with CT or MRI available for review
- Combined positive score (CPS) greater than 1%
- Age 18 years or older at consent
- ECOG performance status 0 or 1
- Leukocytes at least 3 x 10^9/L
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelets at least 100 x 10^9/L
- Hemoglobin at least 9 g/dL (transfusions allowed to reach this level)
- Total bilirubin at most 1.5 times institutional upper limit of normal
- AST and ALT at most 2.5 times institutional upper limit of normal
- Creatinine within normal limits or clearance at least 30 mL/min/1.73 m^2 if elevated
- Use of effective contraception for participants of childbearing potential during and up to 3 months after treatment, or surgical sterilization
- Ability to understand and sign informed consent
- Willingness to adhere to study visits and protocol
You will not qualify if you...
- Nasopharyngeal, salivary gland, 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 therapy within 3 weeks before study start
- Hypersensitivity to losartan or its components
- Radiation therapy within 6 months before study start
- Disease involving more than 50% of the carotid artery
- Incomplete recovery (CTCAE grade greater than 1) from prior cancer treatment side effects except alopecia
- Major surgery (except diagnostic biopsy) within 28 days before study start
- Significant bleeding or infection requiring parenteral antibiotics within 4 weeks before study start
- Uncontrolled diabetes (HbA1C above 8.5%) or recent use of aliskiren
- Active autoimmune disorders needing recent systemic treatment, except well-managed inactive disorders
- Current use of systemic corticosteroids over 10 mg prednisone daily
- Current use of ARBs or ACE inhibitors for hypertension
- Significant cardiovascular, pulmonary, endocrine, neurologic, gastrointestinal, or genitourinary disease unrelated to cancer
- Other active cancers except certain low-risk prostate or skin cancers
- Positive hepatitis C, B, or HIV antibody without negative viral loads
- Live vaccine within 28 days before study start
- Prior treatment with losartan or other TGF-beta directed therapy
- Treatment with another investigational drug or approved therapy for investigational use within 28 days or five half-lives
- Pregnant or breastfeeding
- Any condition interfering with safety, compliance, or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - 1 week
Participants take losartan orally once daily before starting radiation therapy.
1 visit to start medication
Duration - Up to 1 year
Participants receive stereotactic body radiation therapy 2-3 times per week for approximately 2 weeks, followed by pembrolizumab intravenously every 3 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity.
Radiation visits 2-3 times per week for ~2 weeks; pembrolizumab visits every 3 weeks during treatment
Duration - Up to 1 year
After completing treatment, participants are followed up to monitor safety and disease status.
1 visit at 30 days post-treatment, then visits every 3 months for up to 1 year
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
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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