Exercise to Boost Response to Checkpoint Blockade Immunotherapy (NCT05358938) | Clinical Trial Compass
Active ā Not RecruitingEarly Phase 1
Exercise to Boost Response to Checkpoint Blockade Immunotherapy
United States22 participantsStarted 2022-06-21
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria:
* Age ā„ 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.
What they're measuring
1
Participants Consenting to Trial
Timeframe: Up to 12 months
2
Participants Completing Exercise
Timeframe: Up to 12 months
3
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting