Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT07564570
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 30 Minutes Cycle Ergometer — BEHAVIORAL
    Moderate physical activity for 30 minutes on a cycle ergometer

Study Details

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.

Key Dates

First listed
May 4, 2026
Start date
Nov 14, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Control Arm
    Treatment as standard of care
  • Experimental: Sport
    Before the start of therapy: Bicycle spiroergometry is performed to assess physical performance and to determine the anaerobic threshold, as well as to establish the heart rate range corresponding to an exertion level of 60-65% of maximal capacity. Prior to the first four immunotherapy infusions (administered every three weeks), patients perform moderate physical exercise on a cycle ergometer at 60-65% of maximal power output for 30 minutes. This exercise is performed immediately before the infusion. Exercise intensity is controlled using the heart rate range determined during the initial performance assessment. This intervention is repeated for a total of four times before the first 4 infusions of standard-of-care ICI.

Primary Outcome Measure

Feasibility rate [ Time Frame: 9 weeks ]

Central Contacts

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