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NCT Number: NCT07564570

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

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

Location status: Recruiting

Location contact

Julian Koett, MD

CONTACT

[email protected]

+49 40 7410 0

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

30 Minutes Cycle Ergometer

Behavioral

Moderate physical activity for 30 minutes on a cycle ergometer

Primary outcomes

  1. Feasibility rate

    Time frame: 9 weeks

    Rate of >70%

Secondary outcomes

  1. PFS

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

    Median time is reported

  2. 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

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

  3. OS

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

    Median OS is reported.

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

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

    Absolute concentrations

  5. Side effects

    Time frame: 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.

    Amount of patients and fraction experiencing AE and grade according to CTCAE v4.0 is reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Tintelnot, MD

CONTACT

[email protected]

+49 040 7410 0

Julian Kött, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma

Acronym: SPRINT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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