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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Contact Information
Primary
Joseph Tintelnot, MD
j.tintelnot@uke.de
+49 040 7410 0
Backup
Julian Kött, MD
j.koett@uke.de
Time Frame
Start Date: 2025-11-14
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov