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

NCT07307833 | Enrolling By Invitation

• 3 other identifiers: MC250709NCI-2025-0855822-009510
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (3)

• Change in clinically significant vestibulopathy - vestibular function

  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

• Change in clinically significant vestibulopathy - hearing level

  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)

  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

Study Arms (1)

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

Interventions

Non-Interventional Study OTHER

Non-interventional study

Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Concurrent chemotherapy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Carrlene B. Donald, PA-C, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)