63
Participants
Start Date
March 26, 2019
Primary Completion Date
May 31, 2025
Study Completion Date
January 31, 2027
Vinblastine
"* Experimentals Arm A or C (First stage): 2 mg/m2/day IV, weekly per cycle, 28 days cycle~* Experimental Arms Metronomic or Metronomic+Nivolumab (second stage): see C"
Cyclophosphamide
"* Arm A (First stage): 30 mg/m2/day PO, D1-4// D8-11// D15-18// D22-25 per cycle, 28 days cycle~* Arm C (First stage): 30 mg/m2/day PO, D1-D4// D15-D18 per cycle, 28 days cycle~* Metronomic or Metronomic+Nivolumab Arm (second stage): see C"
Capecitabine
"* Arm B (First stage): 400 to 600 mg/m2/day PO, all days per cycle, 28 days cycle~* Arm C (First stage): 400 to 600 mg/m2/day PO, D8-D11// D22-D25 per cycle, 28 days cycle~* Metronomic or Metronomic+Nivolumab Arm (second stage): see C"
Nivolumab
"* Arm A, B or C (First stage): 3 mg/kg IV, D1 \& D15 per cycle, 28 days cycle~* Metronomic+Nivolumab Arm (second stage): 3 mg/kg IV, D1 \& D15 per cycle, 28 days cycle"
Cliniques Universitaires Saint-Luc (CUSL), Brussels
University Hospital Ghent, Ghent
University Hospital Leuven, Leuven
Centre Oscar Lambret, Lille
Centre Léon Bérard (IHOPe), Lyon
Hôpital La Timone, AP-HM, Marseille
Hôpital d'Enfants - CHRU Nancy, Nancy
Hôpital Mère-Enfant, CHU Nantes, Nantes
Institut Curie, Paris
Hôpital de Hautepierre, CHRU Strasbourg, Strasbourg
Hôpital des Enfants - CHU Toulouse, Toulouse
Collaborators (1)
Anticancer Fund, Belgium
OTHER
Bristol-Myers Squibb
INDUSTRY
CTD-CNO
UNKNOWN
ECS-Progastrin SA
INDUSTRY
Centre Oscar Lambret
OTHER