Exercise to Boost Response to Checkpoint Blockade Immunotherapy in Patients with Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, or Merkel Cell Carcinoma

Status: closed to accrual and intervention

This clinical trial examines an exercise intervention in boosting response to checkpoint blockade immunotherapy in patients with cutaneous (involving the skin) melanoma, cutaneous squamous cell carcinoma, or Merkel cell carcinoma. Regular physical activity has a positive impact on chronic diseases. Routine exercise may also alter the biomarker profile of tumors in patients with cancer. A biomarker is a substance, measured in blood or tissue that may reflect the severity or presence of a disease. Biomarker analysis may help determine how serious the disease is or assess early signs that a drug is working, and to help researchers understand why some people will respond to or experience side effects from treatment, while others do not. Coupling exercise with the administration of checkpoint blockade immunotherapy may help increase the effectiveness of checkpoint blockade immunotherapy resulting in better outcomes for patients.

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 response to “Can you currently walk unaided for six minutes of more?”
Scheduled for first-time checkpoint blockade immunotherapy with Food and Drug Administration (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) * Cutaneous squamous cell carcinoma (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

PRIMARY OBJECTIVES:

I. To determine the acceptability of the exercise intervention and feasibility of patients to complete 30 minutes of supervised moderate exercise on the same day as receiving checkpoint blockade immunotherapy.

II. To estimate the impact of exercise on tumor immunological biomarkers and disease outcome.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete moderate exercise on a stationary bike or treadmill over 30 minutes prior to administration of standard-of-care checkpoint blockade immunotherapy across all cycles. Patients also undergo collection of blood samples and may undergo optional biopsy on study.

ARM II: Patients receive standard clinical care during standard-of-care checkpoint blockage immunotherapy. Patients also undergo collection of blood samples and may undergo optional biopsy on study.

After completion of study treatment, patients are followed for up to 5 years after the end of treatment with immunotherapy.

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Exercise to Boost Response to Checkpoint Blockade Immunotherapy in Patients with Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, or Merkel Cell Carcinoma

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