Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Not Applicable

Recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma; Merkel Cell Carcinoma; Cutaneous Melanoma
• Interventions: Other: Exercise Test

• Registration Number: NCT06008977
• Lead Sponsor: AdventHealth Translational Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-24
• Status Verified: 2024-06
• Study Start: 2024-06-03
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Males and females ≥18 years of age.

2. Able to read and speak English fluently.

3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?"

4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy) with the following diagnosis:

   1. Adjuvant setting: cutaneous melanoma.
   2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma.

5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.

6. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

Exclusion Criteria

7. Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval.
8. Presence of major postoperative complications for which an exercise intervention may be contraindicated.
9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report.
10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing).
11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group- Moderate Exercise (Neoadjuvant)	Exercise Test	Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.
Intervention Group- Moderate Exercise (adjuvant)	Exercise Test	Patients randomized to the exercise arm will complete up to 30 minutes of same-day exercise prior to each administration of checkpoint blockade immunotherapy across all cycles. The preferred exercise is 30 minutes of moderate exertion on a cycle ergometer.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AdventHealth Translational Research Institute; 🇺🇸 Orlando, Florida, United States