Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Description

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.

Conditions

Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma

Study Overview

Study Details

Study overview

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.

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Condition
Cutaneous Melanoma
Intervention / Treatment

-

Contacts and Locations

Orlando

AdventHealth Translational Research Institute, Orlando, Florida, United States, 32804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AdventHealth Translational Research Institute,

Bret Goodpaster, PhD, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

2025-05