Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

March 26, 2019

Primary Completion Date

May 31, 2025

Study Completion Date

January 31, 2027

Conditions
Childhood Solid Tumor
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

DRUG

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"

Trial Locations (11)

Unknown

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Anticancer Fund, Belgium

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

CTD-CNO

UNKNOWN

collaborator

ECS-Progastrin SA

INDUSTRY

lead

Centre Oscar Lambret

OTHER

NCT03585465 - Nivolumab in Combination With Metronomic Chemotherapy in Paediatrics Refractory / Relapsing Solid Tumors | Biotech Hunter | Biotech Hunter