NCT07564570Recruiting
Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
The aim of this research project is to determine whether a short bout of physical exercise immediately before the start of immunotherapy (Nivolumab and Ipilimumab) is feasible and has a positive effect on the effectiveness of immunotherapy. It is known that short-term physical exercise leads to marked changes in the innate and adaptive immune system. These changes-specifically an increase in natural killer (NK) cells and cytotoxic T cells-are associated with a better response to immunotherapy. The patient population selected for this study consists of patients with advanced-stage melanoma who are receiving Nivolumab and Ipilimumab. First, we aim to assess whether such an intervention is feasible in a large proportion of patients, as many patients experience disease-related and treatment-related side effects. Secondary objectives are to demonstrate that the exercise intervention positively influences the immune system and that this, in turn, leads to an improved response to therapy, thereby positively affecting patient survival, improving quality of life, and reducing treatment-related side effects.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 14 Nov 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT07564570
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 14 Nov 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with an active infection requiring systemic therapy.
- Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.