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Exercise to Boost Response to Checkpoint Blockade Immunotherapy (EX-BOOST)
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.
Details
| Lead sponsor | AdventHealth Translational Research Institute |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 12 |
| Start date | 2024-06-03 |
| Completion | 2026-12 |
Conditions
- Cutaneous Melanoma
- Cutaneous Squamous Cell Carcinoma
- Merkel Cell Carcinoma
Interventions
- Exercise Test
Primary outcomes
- Relapse-free survival — 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. - Pathological complete response (pCR) — 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.
Countries
United States