Actively Recruiting
Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic malignant melanoma with an indication for immunotherapy (Nivolumab and Ipilimumab).
- Participant provides written informed consent.
- Participant is at least 18 years old at consent.
- No prior systemic anticancer therapy for metastatic disease.
- ECOG performance status score of 2 or lower.
- No physical impairment preventing participation in physical exercise.
You will not qualify if you...
- Major surgery within 2 weeks before starting the study or incomplete recovery from previous surgery.
- Diagnosed immunodeficiency or receiving chronic systemic corticosteroids over 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first study medication dose.
- Active infection requiring systemic treatment.
- Known history of HIV or hepatitis infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
Actively Recruiting
Research Team
J
Joseph Tintelnot, MD
CONTACT
J
Julian Kött, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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