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NCT06211335 · ClinicalTrials.gov registry record · Phase 1

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 of Metastatic Head-and-neck Squamous-cell Carcinoma and Locally Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by University of California, Davis.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
2
Study locations

NCT06211335: Recruiting Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Locally Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by University of California, Davis.

NCT06211335 is a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Locally Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 24 participants, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06211335, a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Locally Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by University of California, Davis.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
2
Study locations

Study 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 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.

Primary Outcome

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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • RADIATION Stereotactic Body Radiation Therapy
  • DRUG Losartan

Study Locations (2)

California

  • University of California Davis Comprehensive Cancer Center - Sacramento

Colorado

  • University of Colorado Denver | Anschutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-12-07
Est. Completion 2027-06
Phase Phase 1
University of California, Davis

657 total trials

What NCT06211335 shows while recruiting

NCT06211335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (81% lower).

The record links to 3 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT06211335 reports a single indexed study location in California, Colorado.

Frequently Asked Questions

What is clinical trial NCT06211335 about?

NCT06211335 is a clinical study titled "Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma". 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 rec...

What is the current status of trial NCT06211335?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-12-07. Estimated completion is 2027-06.

What conditions does trial NCT06211335 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Refractory Head and Neck Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06211335?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION), Losartan (DRUG).

Who is sponsoring clinical trial NCT06211335?

This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06211335 being conducted?

This trial has 2 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Head-and-neck Squamous-cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06211335's enrollment target sits among peer trials

24 22nd of 24 higher than 3 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06211335, the US trial registry maintained by the National Library of Medicine. NCT06211335 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.