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Active, Not Recruiting

NCT Number: NCT06008977

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Exercise test

Other

Supervised pedaling on an ergometer (stationary bike) at a moderate pace for a goal of 30 minutes. The exercise test will be scheduled at infusion visits 1, 6, and 12 or 1 and 3 over the treatment cycle, depending on the group assignment.

Primary outcomes

  1. Relapse-free survival

    Time frame: Up to 12 months

    For patients treated in the adjuvant setting. Total study duration is dependent upon oncology therapy.

    Recurrence-free survival will be assessed.

  2. Pathological complete response (pCR)

    Time frame: Up to 12 months

    For patients treated in the neoadjuvant setting. All neoadjuvant patients will have remaining tumor and, when appropriate, its associated nodal basin removed after completion of checkpoint blockade immunotherapy. Total study duration is dependent upon oncology therapy.

    This will be measured in excised tissues after standard-of-care surgery post completion of checkpoint blockade immunotherapy.

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Acronym: EX-BOOST

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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