30-minute cycling immediately before nivolumab and ipilimumab for metastatic melanoma
SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma
This trial will test whether a 30-minute cycling session immediately before nivolumab plus ipilimumab boosts immune activity and improves outcomes for people with metastatic melanoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Drugs / interventions | Nivolumab, Ipilimumab, immunotherapy, prednisone |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT07564570 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic melanoma starting first-line nivolumab plus ipilimumab, ECOG performance status ≤2, who can safely perform a 30-minute cycling session and provide informed consent.
Not a fit: Patients unable to tolerate exercise, those with active immunodeficiency or recent high-dose steroids, those with prior systemic therapy for metastatic disease, or with severe comorbidities are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could amplify the immune response around dosing and improve response rates to checkpoint inhibitor therapy.
How similar studies have performed: Acute exercise is known to mobilize NK and cytotoxic T cells and small studies suggest immune modulation by exercise, but applying a brief exercise bout immediately before checkpoint inhibitor therapy is largely novel with limited direct clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.