30-minute cycling immediately before nivolumab and ipilimumab for metastatic melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center interventional study at the University Medical Center Hamburg-Eppendorf, patients with metastatic melanoma scheduled to start first-line nivolumab plus ipilimumab perform a 30-minute bout of exercise on a cycle ergometer immediately before their infusion. The primary goal is to determine feasibility—whether a large proportion of patients can complete the intervention despite disease- and treatment-related symptoms. Secondary measures include acute immune changes such as increases in natural killer cells and cytotoxic T cells and correlation of those changes with treatment response. Eligible participants are adults with histologically confirmed metastatic melanoma, ECOG ≤2, no prior systemic therapy for metastatic disease, and no contraindication to exercise or active immunosuppression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed metastatic malignant melanoma with an indication for immunotherapy (Nivolumab and Ipilimumab).
* The participant provides written informed consent for the study.
* The participant is at least 18 years of age on the day the informed consent is signed.
* No prior systemic anticancer therapy for metastatic disease (e.g., cytotoxic or targeted agents).
* ECOG (Eastern Cooperative Oncology Group) performance status score of ≤ 2.
* No physical impairment that would preclude participation in physical exercise.

Exclusion Criteria:

* Major surgery within 2 weeks prior to the start of the study intervention, or participants who have not fully recovered from the effects of a previous surgery.
* Participants with a diagnosed immunodeficiency, or those receiving chronic systemic corticosteroid therapy (at a dose greater than 10 mg prednisone equivalent per day), or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study medication.
* Participants with an active infection requiring systemic therapy.
* Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.

Where it's running

• University Medical Center Hamburg-Eppendorf
  Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting

Study contacts

• Study coordinator: Joseph Tintelnot, MD
• Email: j.tintelnot@uke.de
• Phone: +49 040 7410 0

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.