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New treatment option for Metastatic Melanoma
Official title Physical Activity Directly Before Immunotherapy (Nivolumab and Ipilimumab) in Melanoma
ClinicalTrials.gov ID: NCT07564570
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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.
You likely can't join 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...
- Participants with a diagnosed immunodeficiency, or those receiving chronic systemic corticosteroid therapy (at a dose greater than 10 mg prednisone...
- Participants with an active infection requiring systemic therapy.
- Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.
See the full eligibility 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.
- 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...
- Participants with an active infection requiring systemic therapy.
- Participants with a known history of infection with human immunodeficiency virus (HIV) or hepatitis.
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.