Exercise to Boost Response to Checkpoint Blockade Immunotherapy

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Active, not recruiting; Early Phase 1

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

Treatments: Other: Exercise; Drug: Checkpoint Blockade, Immune

Study type: Interventional

Funder types: Other

Identifiers

NCT05358938

MCC-20854

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 4 patient groups

Adjuvant Arm with Exercise

Experimental group

Description:

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.

Treatment:

Drug: Checkpoint Blockade, Immune

Other: Exercise

Adjuvant Arm without Exercise

Active Comparator group

Description:

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.

Treatment:

Drug: Checkpoint Blockade, Immune

Neoadjuvant Arm with Exercise

Experimental group

Description:

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.

Treatment:

Drug: Checkpoint Blockade, Immune

Other: Exercise

Neoadjuvant Arm without Exercise

Active Comparator group

Description:

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.

Treatment:

Drug: Checkpoint Blockade, Immune