45
Participants
Start Date
January 2, 2019
Primary Completion Date
June 30, 2025
Study Completion Date
September 30, 2025
Nivolumab cohort 1
Induction: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) iv Q2W until CR Evaluation of response as defined below, including biopsy in case of residual masses at Week 24 Maintenance: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) Q4W Total duration of treatment (induction + maintenance) = 24 months
Nivolumab cohort 2
Induction: nivolumab 3 mg/kg iv Q2W for 4 doses (Wk0, Wk2, Wk4 and Wk6) Maintenance: nivolumab 3 mg/kg Q4W, for 25 doses, starting at Week 8 (14 days after the last induction dose) Total duration of treatment (induction + maintenance) = 24 months
CHU Toulouse Hopital des enfants, Toulouse
IUC Toulouse, Toulouse
CHU Bordeaux Hopital Pellegrin, Bordeaux
CHU de nancy, Vandœuvre-lès-Nancy
Centre Léon Berard Lyon, Lyon
Hôpital Saint Louis, Paris
Hôpital Trousseau, Paris
Gustave Roussy, Villejuif
Rigshospitalet, Copenhagen
CHU Bordeaux, Bordeaux
CHU Mondor, Créteil
Centre Oscar Lambret, Lille
Women'S and Children'S Nhs Foundation Trust, Birmingham
Gustave Roussy, Cancer Campus, Grand Paris
OTHER