Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05358938

Collaborator

(none)

Enrollment

Location

Arms

24.2

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Melanoma Cutaneous Squamous Cell Carcinoma Merkel Cell Carcinoma	Other: Excerise Drug: Checkpoint Blockade, Immune	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

Actual Study Start Date :

Apr 26, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant Arm with Exercise - 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. Adjuvant participants will receive 12 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab, 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: Excerise 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 Drug: Checkpoint Blockade, Immune Adjuvant participants will receive 12 cycles of check point blockade therapy and Neoadjuvant participants will receive 4 cycles of check point blockade therapy. This treatment is standard of care. Other Names: Avelumab Cemiplimab Ipilimumab Pembrolizumab
Active Comparator: Adjuvant Arm without Exercise Participants will receive clinical care following Moffitt standards for the patients disease type and therapeutic setting. Adjuvant participants will receive 12 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab, 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 and third infusion dates.	Drug: Checkpoint Blockade, Immune Adjuvant participants will receive 12 cycles of check point blockade therapy and Neoadjuvant participants will receive 4 cycles of check point blockade therapy. This treatment is standard of care. Other Names: Avelumab Cemiplimab Ipilimumab Pembrolizumab
Experimental: NeoAdjuvant Arm with Exercise • Arm - 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 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab, 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: Excerise 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 Drug: Checkpoint Blockade, Immune Adjuvant participants will receive 12 cycles of check point blockade therapy and Neoadjuvant participants will receive 4 cycles of check point blockade therapy. This treatment is standard of care. Other Names: Avelumab Cemiplimab Ipilimumab Pembrolizumab
Active Comparator: NeoAdjuvant Arm without Exercise Participants will receive clinical care following Moffitt standards for the patients disease type and therapeutic setting. Neoadjuvant participants will receive 4 cycles of therapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab, 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 and third infusion dates.	Drug: Checkpoint Blockade, Immune Adjuvant participants will receive 12 cycles of check point blockade therapy and Neoadjuvant participants will receive 4 cycles of check point blockade therapy. This treatment is standard of care. Other Names: Avelumab Cemiplimab Ipilimumab Pembrolizumab

Outcome Measures

Primary Outcome Measures

Participants Consenting to Trial [Up to 12 months]
Proportion of patients approached who consent to participate in study, and investigators will determine the 95% confidence interval
Participants Completing Exercise [Up to 12 months]
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.
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting [Up to 12 Months]
The length of time without signs or symptoms of cancer
Impact of Exercise on Tumor Immunological Biomarkers - Neoadjuvant Setting [Up to 4 Months]
The length of time without signs or symptoms of cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:
Age ≥ 18 years
Able to read and speak English fluently
Capable of giving informed consent
Patient has received a complete COVID-19 vaccination series.
Reported ability to complete 20-30 minutes moderate exercise per positive response on the six-minute walk test
Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab 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)

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.