NCT07564570 Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
| NCT ID | NCT07564570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Metastatic Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-11-14 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07564570 clinical trial?
This trial is open to participants of all sexes, studying Metastatic Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564570 currently recruiting?
Yes, NCT07564570 is actively recruiting participants. Contact the research team at j.tintelnot@uke.de for enrollment information.
Where is the NCT07564570 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT07564570 clinical trial?
NCT07564570 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 40 participants.
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