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

Universitätsklinikum Hamburg-Eppendorf

Status: Enrolling

Conditions: Metastatic Melanoma

Treatments: Behavioral: 30 Minutes Cycle Ergometer

Study type: Interventional

Funder types: Other

Identifiers

NCT07564570

Version 1.0

Details and patient eligibility

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Treatment as standard of care

Sport

Experimental group

Description:

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.

Treatment:

Behavioral: 30 Minutes Cycle Ergometer