Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Study Overview
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Brief Summary
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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

Official Title
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Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Conditions
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Cutaneous Melanoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma

Intervention / Treatment
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* Other: Exercise
* Drug: Checkpoint Blockade, Immune


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Arm with Exercise<br>Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. Adjuvant participants will receive 1 year [currently 9-18 cycles] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab or relatlimab, or currently approved standard of care treatment, either alone or in combination. Participants also will complete 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. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates. | Other: Exercise<br>* 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<br>Drug: Checkpoint Blockade, Immune<br>* Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.<br>* Other names: Pembrolizumab;|
| Active Comparator: Adjuvant Arm without Exercise<br>Participants will receive clinical care following Moffitt standards for the patients disease type and therapeutic setting. Adjuvant participants will receive one year [currently 9-18 cycles] of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, relatlimab, or currently approved standard of care treatment, either alone or in combination. Blood samples will be collected at 1) baseline (upon arrival to clinic) and 2) post-infusion. Blood samples will be obtained on the first, third, midpoint, and final infusion dates. | Drug: Checkpoint Blockade, Immune<br>* Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.<br>* Other names: Pembrolizumab;|
| Experimental: Neoadjuvant Arm with Exercise<br>Participants will complete 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. Neoadjuvant participants will receive up to 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, or relatlimab, or currently approved standard of care treatment, either alone or in combination. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first and third infusion dates. | Other: Exercise<br>* 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<br>Drug: Checkpoint Blockade, Immune<br>* Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.<br>* Other names: Pembrolizumab;|
| Active Comparator: Neoadjuvant Arm without Exercise<br>Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting. Neoadjuvant participants will receive up to 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, pembrolizumab, or relatlimab, or currently approved standard of care treatment, either alone or in combination. Participants also will complete 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. Blood samples will be collected at 1) baseline (upon arrival to clinic), 2) post-exercise, and 3) post-infusion. Blood samples will be obtained on the first and third infusion dates. | Drug: Checkpoint Blockade, Immune<br>* Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.<br>* Other names: Pembrolizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Consenting to Trial | Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval | Up to 12 months | 
| Participants Completing Exercise | Proportion of participants randomized to the exercise intervention who complete at least 75% of schedule exercise routines; 95% CI will be determined for this proportion. | Up to 12 months | 
| Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting | The length of time without signs or symptoms of cancer | Up to 12 Months | 
| Pathological Complete Response (pCR) - Neoadjuvant Setting | The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells. | Up to 4 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Checkpoint Blockade Immunotherapy, Immunotherapy, Skin Cancer