Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Running, not enrolling · Not applicable

Conditions studied: Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06008977

Run by

AdventHealth Translational Research Institute

People needed

12

Starts

2024-06-03

Expected to finish

2026-12-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ≥18 years of age.
• Able to read and speak English fluently.
• Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"
• 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:
• Adjuvant setting: cutaneous melanoma.
• Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.
• States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
• 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.

You may not qualify if…

• 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.
• Presence of major postoperative complications for which an exercise intervention may be contraindicated.
• Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
• Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).
• 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.

Where it is running

• AdventHealth Translational Research Institute — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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