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Angiotensin II Receptor Blocker

Treatment (losartan, SBRT, pembrolizumab) for Head and Neck Squamous Cell Carcinoma

Phase 1

Recruiting

Led By Shyam S.D. Rao, MD, PhD

Research Sponsored by Shyam S.D. Rao

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cr or pr until progressive disease, death or last tumor assessment using recist 1.1, up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and side effects of combining losartan, pembrolizumab, and stereotactic body radiation therapy (SBRT) to treat patients with head and neck squ

Who is the study for?

This trial is for adults with head and neck squamous cell carcinoma that has returned, resisted treatment, or spread to a few other places. Participants should have tried previous therapies without success and must be able to handle radiation therapy.Check my eligibility

What is being tested?

The trial tests combining losartan (a blood pressure medication), pembrolizumab (an immunotherapy drug), and precise radiation therapy. It aims to see if this mix can better treat cancer by enhancing the immune system's response and targeting tumors while sparing healthy tissue.See study design

What are the potential side effects?

Possible side effects include high blood pressure changes due to losartan, immune-related reactions from pembrolizumab like fatigue, skin issues or organ inflammation, and typical radiation effects such as localized skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the head or neck area cannot be surgically removed and has returned or spread, but only to a few places.

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My cancer can be measured and tracked using CT or MRI scans.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My kidney function is within the normal range or minimally lower.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cr or pr until progressive disease, death or last tumor assessment using recist 1.1, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cr or pr until progressive disease, death or last tumor assessment using recist 1.1, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cr or pr until progressive disease, death or last tumor assessment using recist 1.1, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment related adverse events

Secondary outcome measures

Duration of response

Objective response rate

Overall survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (losartan, SBRT, pembrolizumab)Experimental Treatment3 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,712 Total Patients Enrolled

Shyam S.D. RaoLead Sponsor

Shyam S.D. Rao, MD, PhDPrincipal InvestigatorUniversity of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants in this medical study at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this particular study is actively seeking participants. The trial was initially posted on December 7th, 2023 and recently updated on January 8th, 2024. The objective of the study is to enroll a total of 24 patients from a single designated site."

Answered by AI

What is the level of safety associated with administering losartan, SBRT, and pembrolizumab as a combined treatment for individuals?

"Given that this is a Phase 1 trial, our team at Power assesses the safety of Treatment (losartan, SBRT, pembrolizumab) to be rated as 1 on a scale from 1 to 3. This rating indicates limited data supporting both safety and efficacy for this treatment regimen."

Answered by AI

What is the current number of individuals being enrolled in this research project?

"Indeed, according to the details provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on December 7th, 2023 and it was last edited on January 8th, 2024. The study aims to enroll a total of 24 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma

Shyam S.D. Rao 2023. "Losartan, Pembrolizumab and Stereotactic Body Radiation Therapy for the Treatment of Patients With Locally Recurrent, Refractory or Oligometastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06211335.

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