Exercise to enhance response to immunotherapy in skin cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the feasibility of implementing an exercise intervention for patients with cutaneous cancers, such as melanoma and squamous cell carcinoma, who are scheduled to receive checkpoint blockade immunotherapy. Participants will engage in a day-of-therapy exercise regimen to evaluate its impact on treatment response. The study will gather preliminary data on how exercise may influence the effectiveness of immunotherapy in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Bret Goodpaster, PhD — Study Principal Investigator
• Study coordinator: Recruitment Department
• Email: Fh.tri.recruitment@adventhealth.com
• Phone: 407-303-7100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Cemiplimab before surgery for skin cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.