Metastatic MelanomaSPRINTNCT07564570
Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
A study testing 30 Minutes Cycle Ergometer in people with Metastatic Melanoma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- 30 Minutes Cycle Ergometer
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Julian Kött, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
Julian Koett, MD, +49 40 7410 0, j.koett@uke.de
About this study
Official title: 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.
Read more
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
- Being tested
- 30 Minutes Cycle Ergometer
- Keywords
- exercise, Immunotherapy, Melanoma, Nivolumab, Ipilimumab
- Medical subject headings
- Melanoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Minutes Cycle ErgometerBehavioural
Moderate physical activity for 30 minutes on a cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 30 Minutes Cycle Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility rate
Rate of >70%
Measured: 9 weeks
Secondary outcomes (5)
PFS
Median time is reported
Measured: 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
Measured: Difference calculated between blood draw directly before and directly after sport intervention.
OS
Median OS is reported.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start14 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564570
- Sponsor's protocol ID
- Version 1.0
- Acronym
- SPRINT
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPRINT - Short Moderate Physical Regime INtervention Directly Before ImmunoTherapy for Melanoma
- ClinicalTrials.gov ID
- NCT07564570
- Acronym / sponsor ID
- SPRINT / Version 1.0
- Conditions
- Metastatic Melanoma
- Keywords
- exercise, Immunotherapy, Melanoma, Nivolumab, Ipilimumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Treatment as standard of care |
| Sport | Experimental | Behavioral: 30 Minutes Cycle ErgometerBefore 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 Minutes Cycle ErgometerModerate physical activity for 30 minutes on a cycle ergometer | Behavioural | Sport |
Primary outcome
Feasibility rate
Time frame: 9 weeks
Rate of >70%
5 secondary outcomes
PFS
Time frame: 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
Time frame: Difference calculated between blood draw directly before and directly after sport intervention.
OS
Time frame: 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
Time frame: Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julian Kött, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 Minutes Cycle Ergometer in people with Metastatic Melanoma, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Tintelnot, MD (+49 040 7410 0, j.tintelnot@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility rate (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.