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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Joseph Tintelnot, MD
- Numéro de téléphone: +49 040 7410 0
- E-mail: j.tintelnot@uke.de
Sauvegarde des contacts de l'étude
- Nom: Julian Kött, MD
- E-mail: j.koett@uke.de
Lieux d'étude
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Free and Hanseatic City of Hamburg
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Hamburg, Free and Hanseatic City of Hamburg, Allemagne, 20251
- Recrutement
- University Medical Center Hamburg-Eppendorf
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Contact:
- Julian Koett, MD
- Numéro de téléphone: +49 40 7410 0
- E-mail: j.koett@uke.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Control Arm
Treatment as standard of care
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Expérimental: 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. |
Moderate physical activity for 30 minutes on a cycle ergometer
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility rate
Délai: 9 weeks
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Rate of >70%
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9 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PFS
Délai: Time from randomization to progression or death from any cause, up to 30 months.
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Median time is reported
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Time from randomization to progression or death from any cause, up to 30 months.
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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
Délai: Difference calculated between blood draw directly before and directly after sport intervention.
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Difference calculated between blood draw directly before and directly after sport intervention.
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OS
Délai: Time from randomization to progression or death from any cause, up to 30 months.
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Median OS is reported.
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Time from randomization to progression or death from any cause, up to 30 months.
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Increase of cytokines and chemokines, i.e. IL-15 after cycling
Délai: Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
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Absolute concentrations
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Difference measured from the blood draw directly before and the blood draw directly after the sport intervention.
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Side effects
Délai: 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.
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Amount of patients and fraction experiencing AE and grade according to CTCAE v4.0 is reported.
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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.
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Maladies de la peau
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Tumeurs cutanées
- Comportement
- Maladies de la peau et du tissu conjonctif
- Mélanome
- Activité motrice
Autres numéros d'identification d'étude
- Version 1.0
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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