MedTrace Logo

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

NCT03350126 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-07-23

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Thierry ANDRE, MD · Hopital Saint Antoine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2020-01-10
Completion
2025-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350126 on ClinicalTrials.gov