iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

December 4, 2017

Primary Completion Date

January 10, 2020

Study Completion Date

December 31, 2025

Conditions
Metastatic Cancer Colorectal
Interventions
DRUG

Ipilimumab 200 MG in 40 ML Injection

"Induction therapy (12 weeks):~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W"

DRUG

Nivolumab 10 MG/ML

"Induction therapy (12 weeks) :~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W~Maintenance therapy (40 weeks):~Nivolumab monotherapy IV over 60 minutes Q2W until iRECIST progression or if no PD for one year."

Trial Locations (8)

75012

Hospital Saint Antoine, Paris

Unknown

Institut Sainte Catherine, Avignon

CHRU Besançon, Besançon

Henri Mondor Hospital, Créteil

IHFB, Levallois-Perret

Centre Leon Berard, Lyon

CHU Nantes - Hôtel Dieu, Nantes

CHU Poitiers, Poitiers

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER