Impact of Immunotherapy on Vestibular Function, The Mayo Clinic Arizona Experience

December 26, 2025 updated by: Mayo Clinic
This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who will be initiating single agent immunotherapy with pembrolizumab, cemiplimab, nivolumab, atezolizumab, or dual therapy with ipilimumab/nivolumab or nivolumab/relatlimab.

Description

Inclusion Criteria:

  • At least 18 years of age at screening
  • Patients who will be initiating single agent immunotherapy with pembrolizumab, cemiplimab, nivolumab, atezolizumab, or dual therapy with (Ipilimumab/Nivolumab or Nivolumab/Relatlimab)

Exclusion Criteria:

  • Concurrent chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients undergo vestibular function testing with video head impulse testing, sinusoidal harmonic acceleration testing, and pure tone audiometry and complete questionnaires throughout the study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinically significant vestibulopathy - hearing level
Time Frame: Baseline,12 months
Assessed using Pure Tone Audiometry, a standard hearing test. Any change from baseline (prior to initiating immunotherapy) to 12 months will be reported.
Baseline,12 months
Oscillopsia Severity Questionnaire (OSQ)
Time Frame: Baseline, 3 months, 6 months, 12 months
The OSQ consists of 9 questions to assess visual environment sensation (episodes of oscillopsia). Questions are answered on a 5-point scale: always, often, sometimes, seldom, never. The OSQ is scored by calculating a mean item score, which results in a total score ranging from 1 to 5. A score of 3 or higher indicates moderate to extreme oscillopsia severity.
Baseline, 3 months, 6 months, 12 months
Change in clinically significant vestibulopathy - vestibular function
Time Frame: Baseline, 3 months, 6 months, 12 months
Assessed using standard vestibular function testing. Results will be aggregated to determine overall vestibular function. Results from baseline (prior to initiating immunotherapy) will be compared to results at 3, 6, and 12 months.
Baseline, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Carrlene B. Donald, PA-C, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MC250709 (Other Identifier: Mayo Clinic)
  • NCI-2025-08558 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 22-009510 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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