Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 2, 2019

Primary Completion Date

June 30, 2025

Study Completion Date

September 30, 2025

Conditions
Relapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma
Interventions
DRUG

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

DRUG

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

Trial Locations (13)

31059

CHU Toulouse Hopital des enfants, Toulouse

IUC Toulouse, Toulouse

33076

CHU Bordeaux Hopital Pellegrin, Bordeaux

54500

CHU de nancy, Vandœuvre-lès-Nancy

69008

Centre Léon Berard Lyon, Lyon

75010

Hôpital Saint Louis, Paris

75012

Hôpital Trousseau, Paris

94805

Gustave Roussy, Villejuif

Unknown

Rigshospitalet, Copenhagen

CHU Bordeaux, Bordeaux

CHU Mondor, Créteil

Centre Oscar Lambret, Lille

Women'S and Children'S Nhs Foundation Trust, Birmingham

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

NCT03703050 - Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2) | Biotech Hunter | Biotech Hunter