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Pedaling against cancer: exercise may boost immunotherapy

NCT ID NCT06008977

Knowledge-focused Sponsor: AdventHealth Translational Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study is testing whether a 30-minute stationary bike ride on the same day as immunotherapy can help the treatment work better for people with skin cancers like melanoma. The study involves 12 patients and focuses on whether this exercise plan is practical and safe. Researchers will also look at early signs of cancer response, but the main goal is to gather information for larger future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
supervised stationary bike exercise
What this could lead to
If it works, this could point toward a simple way to improve how well immunotherapy works for skin cancer patients.
What could go wrong
This is a very small pilot study with only 12 people, so results may not apply widely. It is testing feasibility, not yet proving effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

12 people

The number who actually took part.

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and females ≥18 years of age. 2. Able to read and speak English fluently. 3. Reported ability to complete 20-30 minutes moderate exercise per positive response to, "Can you currently walk unaided for six minutes or more?" 4. Scheduled for first-time checkpoint blockade immunotherapy with avelumab, cemiplimab, ipilimumab, nivolumab, or pembrolizumab in the absence of other therapies (e.g. targeted therapy) with the following diagnosis: 1. Adjuvant setting: cutaneous melanoma. 2. Neoadjuvant setting: cutaneous melanoma, cuSCC, or Merkel cell carcinoma. 5. States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study. 6. Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study. Exclusion Criteria: 7. Presence of medical conditions, such as severe cardiovascular disease for which exercise may be contraindicated. Participants may be referred to their medical team to obtain a cardiology approval. 8. Presence of major postoperative complications for which an exercise intervention may be contraindicated. 9. Currently has a chronic, contagious, infectious disease, such as active tuberculosis, active Hepatitis B or C, HIV, or COVID-19, per self-report. 10. Currently pregnant, lactating or planning to become pregnant (positive result on urine pregnancy testing). 11. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma cutaneous neuroendocrine carcinoma melanoma skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous melanoma Cutaneous squamous cell carcinoma Merkel cell carcinoma

Contacts and locations

Locations

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804, United States

More trials for these conditions

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