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

NCT07564570 | Recruiting

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Keywords

exercise; Immunotherapy; Melanoma; Nivolumab; Ipilimumab

Outcome Measures

Primary Outcomes (1)

• Feasibility rate

  Rate of \>70%

  9 weeks

Secondary Outcomes (5)

• PFS

  Time from randomization to progression or death from any cause, up to 30 months.

• Increase of NK cells and T cells or T cell subsets auch as CD103/CD39-positive CD8 T cells in the peripheral blood after cycling

  Difference calculated between blood draw directly before and directly after sport intervention.

• OS

  Time from randomization to progression or death from any cause, up to 30 months.

• Increase of cytokines and chemokines, i.e. IL-15 after cycling

  Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.

• Side effects

  Occurrence of side effects during active therapy with nivolumab and ipilimumab; the rate per patient is calculated from randomization to the end of the trial. Up to 30 months.

Study Arms (2)

Control Arm

NO INTERVENTION

Treatment as standard of care

Sport

EXPERIMENTAL

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.

Behavioral: 30 Minutes Cycle Ergometer

Interventions

30 Minutes Cycle Ergometer BEHAVIORAL

Moderate physical activity for 30 minutes on a cycle ergometer

Sport

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20251, Germany

RECRUITING

MeSH Terms

Conditions

Melanoma; Motor Activity

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Central Study Contacts

Joseph Tintelnot, MD

CONTACT

+49 040 7410 0; j.tintelnot@uke.de

Julian Kött, MD

CONTACT

j.koett@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: May 4, 2026
• Study Start: November 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-02

Locations

DE (1)