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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Behavioral: 30 Minutes Cycle Ergometer

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Tintelnot, MD; Phone Number: +49 040 7410 0; Email: j.tintelnot@uke.de
• Study Contact Backup: Name: Julian Kött, MD; Email: j.koett@uke.de

Study Locations

• Germany
  • Free and Hanseatic City of Hamburg
    • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
      • Recruiting
      • University Medical Center Hamburg-Eppendorf
      • Contact: Julian Koett, MD; Phone Number: +49 40 7410 0; Email: j.koett@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 30 Minutes Cycle Ergometer; Moderate physical activity for 30 minutes on a cycle ergometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility rate	Rate of >70%	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Median time is reported	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	Median OS is reported.	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	Absolute concentrations	Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
Side effects	Amount of patients and fraction experiencing AE and grade according to CTCAE v4.0 is reported.	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.

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: exercise; Nivolumab; Immunotherapy; Melanoma; Ipilimumab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Behavior; Skin and Connective Tissue Diseases; Melanoma; Motor Activity
• Other Study ID Numbers: Version 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No