OncoMatch/Clinical Trials/NCT06211335
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma
Is NCT06211335 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Losartan for locally recurrent head and neck squamous cell carcinoma.
Treatment: Losartan · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) combined positive score (CPS) > 1% (> 1%)
Combined positive score (CPS) > 1%
Required: CDKN2A p16 status known
p16 status known for base of tongue, soft palate, and tonsil cancers
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody
Cannot have received: chemotherapy
Exception: within 3 weeks prior to study day 1
Chemotherapy or other anti-cancer therapy within 3 weeks prior to study day 1
Cannot have received: radiation therapy
Exception: within 6 months prior to study day 1
Radiation therapy within 6 months prior to study day 1
Cannot have received: TGF-β-directed therapy (losartan)
Any prior treatment with losartan or other specific TGF-β-directed therapy
Lab requirements
Blood counts
Leukocytes ≥ 3 × 10^9/L; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
Kidney function
Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m^2 for patients with creatinine above institutional ULN
Liver function
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); AST/ALT ≤ 2.5 × institutional ULN
Leukocytes ≥ 3 × 10^9/L; Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required); Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); AST/ALT ≤ 2.5 × institutional ULN; Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m^2 for patients with creatinine above institutional ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- University of Colorado Denver | Anschutz Medical Campus · Aurora, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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