Exercise to Boost Response to Checkpoint Blockade Immunotherapy

February 4, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjuvant Arm with Exercise
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.
Other: Exercise
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
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Other Names:
  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
  • Cemiplimab
  • Avelumab
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 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.
Drug: Checkpoint Blockade, Immune
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Other Names:
  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
  • Cemiplimab
  • Avelumab
Experimental: Neoadjuvant 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. 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.
Other: Exercise
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
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Other Names:
  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
  • Cemiplimab
  • Avelumab
Active Comparator: Neoadjuvant Arm without Exercise
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.
Drug: Checkpoint Blockade, Immune
Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.
Other Names:
  • Pembrolizumab
  • Nivolumab
  • Ipilimumab
  • Cemiplimab
  • Avelumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Consenting to Trial
Time Frame: Up to 12 months
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
Time Frame: 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.
Up to 12 months
Impact of Exercise on Tumor Immunological Biomarkers - Adjuvant Setting
Time Frame: Up to 12 Months
The length of time without signs or symptoms of cancer
Up to 12 Months
Pathological Complete Response (pCR) - Neoadjuvant Setting
Time Frame: Up to 4 Months
The occurrence of pathological complete response in resected tumor tissue. pCR will be determined by absence of tumor cells.
Up to 4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Peter Kanetsky, PhD, MPH, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Actual)

October 6, 2024

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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