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Locally Recurrent Head and Neck Squamous Cell CarcinomaPhase 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

A Phase 1 study testing Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy in people with Locally Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
7 Dec 2023to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed locoregionally recurrent, refractory, or oligometastatic (at most 4 lesions) squamous cell carcinoma of the head and neck not amenable to curative resection
  • p16 status known for base of tongue, soft palate, and tonsil cancers
  • Tumor amenable to sequential biopsies, and patients willing to undergo sequential tumor biopsies so long as the treating investigator considers them to be clinically safe
  • Prior radiotherapy to the head and neck is allowed. Disease should be limited to up to 4 sites of active disease in the head and neck and/or distant metastatic sites if deemed safely treatable by physician, or adjacent sites treatable in single contiguous target volume with a recommended maximum total tumor dimension (GTV) of < 7.5 cm. However, larger volumes may be allowed after discussion with primary investigator (PI) and careful review of radiation dose constraints
  • Prior systemic therapy is allowed. Patients with locoregional relapses where radiation alone would be indicated are allowed to enroll without prior systemic therapy
  • Presence of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) with a target on a computed tomography (CT) scan or magnetic resonance imaging (MRI) available for review
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  • Combined positive score (CPS) > 1%
  • Age ≥ 18 years at time of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
  • 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)
  • Aspartate transaminase (AST) / alanine transaminase (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
  • The effects of losartan on the developing human fetus are unknown. For this reason, individuals of childbearing potential and male participants with partners of childbearing potential, must agree to use methods of contraception for the duration of study participation (including dosing interruptions) and for up to 3 months after last study treatment; or be surgically sterilized
  • Ability to understand and willingness to sign and date the informed consent form
  • Stated ability and willingness to adhere to the study visit schedule and protocol requirements

Who cannot join

  • Nasopharyngeal carcinoma, salivary gland carcinoma or primary skin squamous cell carcinoma (SCC)
  • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody
  • Chemotherapy or other anti-cancer therapy within 3 weeks prior to study day 1
  • Hypersensitivity to losartan or any component of the formulation
  • Radiation therapy within 6 months prior to study day 1
  • Patients with disease surrounding > 50% of the carotid
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  • Participant who has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 from an adverse event (AE) due to previous cancer therapeutics (i.e., chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy) with the exception of alopecia
  • Major surgery as assessed by the investigator (with the exception of diagnostic biopsy) within ≤ 28 days prior to study day 1 (patients must have completely recovered from any previous surgery prior to study day 1)
  • Clinically significant bleeding ≤ 4 weeks prior to study day 1
  • Requirement for parenteral antibiotics, or any active infection requiring parenteral antibiotic therapy within 4 weeks prior to study day 1
  • Clinically significant or uncontrolled diabetes mellitus (hemoglobin A1C ≤ 8.5%). Patients with diabetes mellitus treated with aliskiren ≤ 7 days prior to study day 1 are excluded
  • Active autoimmune disorders that have required systemic treatment with disease modifying agents, corticosteroids, or immunosuppressive drugs in the past 2 years are excluded. Patients with autoimmune disorder or well-managed or inactive autoimmune disorders, such as Hashimoto's thyroiditis, may be allowed at the discretion of the PI
  • Current use of systemic corticosteroids equivalent to >10 mg of prednisone per day
  • Current use of angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors for management of hypertension
  • Clinically significant cardiovascular, pulmonary, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor that in the judgment of the investigator should preclude treatment with losartan
  • Any other active malignancy except for low-risk prostate cancer previously treated or under active surveillance, uncomplicated and cured basal cell carcinoma, or squamous cell carcinoma of the skin within 5 years of study entry
  • Known history of positive hepatitis C (HCV) antibody, hepatitis B (HBV) surface antigen (HbsAg and HBV core Ab positive), or human immunodeficiency virus (HIV) antibody results. Patients with positive antibody tests are eligible with negative viral loads
  • Administration of live, attenuated vaccine ≤ 28 days prior to study day 1. Administration of inactivated flu vaccines is allowed
  • Any prior treatment with losartan or other specific TGF-β-directed therapy
  • Treatment with another investigational drug or device, or approved therapy for investigational use ≤ 28 days prior to study day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to study day 1, whichever may be longer
  • Pregnant or breast feeding
  • Any condition that in the opinion of the investigator would interfere with the participant's safety, compliance while on trial, or understanding or rendering of informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Office of Clinical Research contact

916-382-6970

OCRReferral@health.ucdavis.edu

United States2 sites, 2 recruiting

  • University of Colorado Denver | Anschutz Medical Campus

    Aurora, Colorado, 80045

    Alice N Weaver, MD, PhD, 720-848-3532, alice.weaver@cuanschutz.edu

    Alice N Weaver, MD, PhD

    Recruiting

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Shyam S.D. Rao, MD, PhD, 916-734-5810, sdrao@ucdavis.edu

    Shyam S. Rao, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

PRIMARY OBJECTIVE:I. Determine the safety and toxicity of losartan in combination with SBRT and subsequently pembrolizumab in patients with locally recurrent, refractory, or oligometastatic head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVES:I. Evaluate objective tumor response.II. Evaluate progression free survival (PFS). III. Evaluate duration of response.IV. Evaluate overall survival (OS).

OUTLINE:Patients receive losartan orally (PO) once daily (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 intravenously (IV) and repeat every 3 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET), tumor biopsy, and blood sample collection throughout the study.After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 1 year.

Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06211335
Study groupRoleWhat they receive
Treatment (losartan, SBRT, pembrolizumab)ExperimentalPatients 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.
Receives: Drug: Losartan; Biological: Pembrolizumab; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment related adverse events

    Classified by severity and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and summarized using descriptive statistics in participants treated with dosage of the agent selected in the safety run.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Objective response rate

    Defined as stable disease, complete response (CR) or partial response (PR) on imaging assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Will be summarized using Kaplan-Meier curves and 95% confidence interval (CI). Median and range will be reported.

    Measured: Up to 2 years

  2. Progression free survival

    According to RECIST 1.1. Will be summarized using Kaplan-Meier curves and 95% CI.

    Measured: From start of stereotactic body radiation therapy (SBRT) to local or distant progression or death due to any cause, up to 2 years

  3. Duration of response

    Median and range will be reported.

    Measured: From CR or PR until progressive disease, death or last tumor assessment using RECIST 1.1, up to 2 years

  4. Overall survival

    Will be summarized using Kaplan-Meier curves and 95% CI.

    Measured: From the start of SBRT to death from any cause, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start7 Dec 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211335
Sponsor's protocol ID
UCDCC311
Other IDs
NCI-2023-10476, UCDCC311, P30CA093373
Status last verified
Mar 2026
First submitted
8 Jan 2024
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy in people with Locally Recurrent Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by University of California, Davis at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Office of Clinical Research (916-382-6970, OCRReferral@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment related adverse events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211335.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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