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Active Not Recruiting
NCT05358938
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
Conditions: Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 22
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Location: Moffitt Cancer Center Tampa Florida
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
Eligibility Criteria
* Inclusion Criteria:
* Age ≥ 18 years
* Able to read and speak English fluently
* Capable of giving informed consent
* 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 FDA-approved drugs, including avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab 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.
Source: ClinicalTrials.gov (NCT05358938). StuddyBuddy aggregates publicly available trial information.