Exercise to Boost Response to Checkpoint Blockade Immunotherapy

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

30 minutes of moderate exercise on an arm ergometer, a cycle ergometer, or a treadmill prior to each administration of standard of care checkpoint blockade immunotherapy across all cycles

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Treatments: Avelumab; Cemiplimab; Immune Checkpoint Inhibitors; Ipilimumab; Pembrolizumab

Criteria

• 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 on the six-minute walk test

• 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)

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.