Exercise to Boost Response to Checkpoint Blockade Immunotherapy
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jun 2022
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedFebruary 6, 2026
February 1, 2026
2.3 years
April 28, 2022
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (4)
Adjuvant Arm with Exercise
EXPERIMENTALParticipants 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.
Adjuvant Arm without Exercise
ACTIVE COMPARATORParticipants 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.
Neoadjuvant Arm with Exercise
EXPERIMENTALParticipants 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.
Neoadjuvant Arm without Exercise
ACTIVE COMPARATORParticipants 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.
Interventions
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
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Kanetsky, PhD, MPH
Moffitt Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2022
First Posted
May 3, 2022
Study Start
June 21, 2022
Primary Completion
October 6, 2024
Study Completion (Estimated)
August 1, 2026
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share