Clinical Trial 20854

• Overview

  Study Title:

  Exercise to Boost Response to Checkpoint Blockade Immunotherapy

  Summary:

  Investigators will obtain preliminary data on an exercise intervention in participants who are receiving checkpoint blockade immunotherapy. Exercise is completed on the same day of immunotherapy infusion. Information collected during this study will inform how exercise may impact immunological biomarkers and disease outcome.

  Objective:

  This pilot study will provide i) information on the feasibility of 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. Aim 1. To determine the acceptability of the exercise intervention and feasibility of patients to complete 20-30 minutes of supervised moderate exercise on the same day as receiving checkpoint blockade immunotherapy. Aim 2. To estimate the impact of exercise on tumor immunological biomarkers and disease outcome.

• Inclusion Criteria

  • Age >18 years
  • Able to read and speak English fluently
  • Capable of giving informed consent
  • Patient has received a complete COVID-19 vaccination series.
  • 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)
  • Melanoma patients (adjuvant setting)
  • Melanoma patients (neoadjuvant setting)
  • cuSCC patients (neoadjuvant setting)
  • Merkel cell carcinoma patients (neoadjuvant setting) Participants may also be required to have a full COVID vaccination series; the most up-to-date best practice guidelines for research at Moffitt Cancer Center will dictate the need for such a vaccination series.

• Exclusion Criteria

  • Presence of medical conditions, such as severe cardiovascular disease for which an exercise intervention may not be warranted.
  • Presence of major postoperative complications for which an exercise intervention may not be warranted.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.