Exercise to Boost Response to Checkpoint Blockade Immunotherapy (EX-BOOST)

AdventHealth Translational Research Institute

Status: Enrolling

Conditions: Cutaneous Squamous Cell Carcinoma; Merkel Cell Carcinoma; Cutaneous Melanoma

Treatments: Other: Exercise Test

Study type: Interventional

Funder types: Other

Identifiers

NCT06008977

1805426

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Standard Group- No Exercise (Adjuvant)

No Intervention group

Description:

Patients randomized to the standard arm will receive clinical care following AH standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Intervention Group- Moderate Exercise (adjuvant)

Active Comparator group

Description:

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.

Treatment:

Other: Exercise Test

Standard Group- No Exercise (Neoadjuvant)

No Intervention group

Description:

Patients randomized to the standard arm will receive clinical care following AH (AdventHealth) standards for the patient's disease type and therapeutic setting. This includes history and physical and laboratory studies to be conducted on each infusion day before clearing the patient for infusion.

Intervention Group- Moderate Exercise (Neoadjuvant)

Active Comparator group

Description:

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.

Treatment:

Other: Exercise Test