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

Conditions

• Metastatic Cancer Colorectal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab 200 MG in 40 ML Injection — DRUG
  Induction therapy (12 weeks): Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W
• Nivolumab 10 MG/ML — DRUG
  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.

Study Details

This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate disease control rate (DCR) by RECIST and iRECIST at 12 weeks. Evaluation of RECIST and iRECIST will be done in each center in order to choose the optimal therapy (Assessment by Investigators). A centralized evaluation of RECIST and iRECIST, will be organized in Saint-Antoine.

Key Dates

Start date

Dec 4, 2017

Status verified

Jul 2025

Primary completion

Jan 10, 2020

Completion

Dec 31, 2025

Study Design

Enrollment

57 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental arm
  Therapy induction (12 weeks) Nivolumab (IV) and Ipilimumab (IV) - every 21 days - 4 cycles Then Nivolumab (IV) alone every 15 days - 20 cycles - until 12 months

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: At 12 weeks ]