Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Launched by ADVENTHEALTH TRANSLATIONAL RESEARCH INSTITUTE · Aug 18, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether exercising on the day of receiving immunotherapy can help improve the treatment response in patients with certain skin cancers, like melanoma, cutaneous squamous cell carcinoma, and Merkel cell carcinoma. The study aims to find out how practical it is to include exercise as part of the treatment plan and to gather early information on how this exercise might affect patients’ responses to the therapy.

To be eligible for this trial, participants need to be at least 18 years old, able to understand and speak English, and capable of doing moderate exercise for 20 to 30 minutes, like walking for six minutes without help. They must also be scheduled for their first dose of specific immunotherapy drugs. Participants will need to agree to follow the exercise guidelines provided and sign a consent form. It’s important to note that those with certain serious health conditions, recent major surgeries, or infectious diseases will not be able to participate for their safety. If you join the study, you can expect to engage in guided exercise sessions on the same day as your treatment while helping researchers learn more about the potential benefits of exercise in cancer therapy.

Gender

ALL

Eligibility criteria

• 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.