MEL-FIT-IO is an umbrella randomized interventional study evaluating a six-month structured resistance exercise and individualized nutritional intervention in patients with malignant melanoma receiving immune checkpoint inhibitors.
Two prespecified doctoral substudies are embedded within the parent study and use the same participants, study groups, randomization, and assessment schedule. No separate randomization is performed for the substudies.
The ultrasound substudy, protocol ORI2026-5 (US-MUMELICI), evaluates the validity and longitudinal responsiveness of skeletal muscle ultrasound. Rectus femoris shear-wave velocity, muscle stiffness, echogenicity, and thigh muscle thickness are compared with magnetic resonance imaging, dual-energy X-ray absorptiometry, and bioelectrical impedance analysis at baseline, 3 months, and 6 months.
The myokine and metabolic substudy, protocol ORI2026-35 (MY-MEL-FIT-IO), evaluates changes in circulating myokines, systemic inflammatory and immune-cell markers, metabolic parameters, body composition, treatment tolerance, and patient-reported outcomes. Biomarker analyses are performed in the prespecified subgroup of participants with metastatic melanoma.
Treatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.
