356
Participants
Start Date
May 1, 2025
Primary Completion Date
March 1, 2028
Study Completion Date
March 1, 2031
Exercise Therapy
The exercise regimen consists of a non-linear aerobic exercise program of 3-4 sessions per week. During days of FMD no exercise will be prescribed.
Fasting-Mimicking Diet
The FMD is a plant-based, low-carbohydrate, low-caloric diet of 4 days , with the fourth day being the day of chemo/immunotherapy. A total of 6 FMD cycles will be administered over the treatment period of 20 weeks.
SOC
Four cycles of an intravenous infusion of pembrolizumab (200 mg) once every 3 weeks plus paclitaxel (80 mg per square meter of body-surface area once weekly) plus carboplatin (at a dose based on an area under the concentration-time curve of 1.5 mg per milliliter per minute) once weekly in the first 12 weeks, followed by four cycles of epirubicin (90 mg per square meter) plus cyclophosphamide (600 mg per square meter) once every 2 weeks plus pembrolizumab 400mg every 6 weeks or pembrolizumab 200mg every 3 weeks in the subsequent 8 weeks.
UZ Antwerpen, Antwerp
Ziekenhuis aan de Stroom, Antwerp
Cliniques universitaires Saint-Luc (UCLouvain), Brussels
UZ Brussel, Brussels
UZ Gent, Ghent
Jessa Ziekenhuis Hasselt, Hasselt
AZ Groeninge, Kortrijk
University Hospital Leuven, Leuven
Centre Hospitalier Universitaire (CHU) UCL Liège, Liège
Centre Hospitalier Universitaire (CHU) UCL Namur, Namur
KU Leuven
OTHER
AZ Groeninge
UNKNOWN
Jessa Ziekenhuis Hasselt
UNKNOWN
UZ Gent, Belgium
UNKNOWN
UZ Antwerpen
UNKNOWN
Ziekenhuis ad Stroom, Antwerpen
UNKNOWN
Institute Gustave Roussy Paris
UNKNOWN
Universitair Ziekenhuis Brussel
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER