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Exercise to Boost Response to Checkpoint Blockade Immunotherapy | Clinical Trials | Clareo Health

RECRUITINGNA

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

NCT06008977•AdventHealth Translational Research Institute

Summary

The purpose of this pilot study will be to provide i) information on feasibility implementing an exercise intervention trial among patients with cutaneous cancers, including melanoma, squamous cell carcinoma (cuSCC), and Merkel cell carcinoma, scheduled to receive checkpoint blockade immunotherapy, and ii) preliminary data on the impact of a day-of-therapy exercise intervention.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females ≥18 years of age.
•2. Able to read and speak English fluently.
•3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"
•4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy) with the following diagnosis:
•1. Adjuvant setting: cutaneous melanoma.
•2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.
•5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
•6. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

Exclusion Criteria

•7. Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval.
•8. Presence of major postoperative complications for which an exercise intervention may be contraindicated.
•9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
•10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).
•11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

Locations (1)

AdventHealth Translational Research Institute

Orlando, Florida, United States

Key Dates

Start Date

June 3, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

June 4, 2025

Enrollment

ESTIMATED participants

Conditions

Cutaneous MelanomaCutaneous Squamous Cell CarcinomaMerkel Cell Carcinoma

Interventions

Exercise Test

OTHER

Contacts

Recruitment Department

CONTACT

407-303-7100 Fh.tri.recruitment@adventhealth.com

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Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Inclusion Criteria

Exclusion Criteria

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