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OpenTrials
Active, Not Recruiting

NCT Number: NCT05358938

Exercise to Boost Response to Checkpoint Blockade Immunotherapy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cutaneous Melanoma Adenocarcinoma Behavior Carcinoma Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Cutaneous Squamous Cell Carcinoma DNA Virus Infections Infections Melanoma Merkel Cell Carcinoma Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Polyomavirus Infections Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Exercise

Other

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

Checkpoint Blockade, Immune

Drug

Participants will receive clinical care following Moffitt standards for the patient's disease type and therapeutic setting.

Other names: Avelumab, Cemiplimab, Ipilimumab, Nivolumab, Pembrolizumab

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
May 3, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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