NCT03350126: NIPICOL

Interest of iRECIST Radiological Assessment for Disease Control Rate (DCR) for Evaluation of Patients With Metastatic Colorectal Cancer dMMR and/or MSI Treated With Nivolumab and Ipilimumab. A GERCOR Open-label Phase II Study NIPICOL C17-01

Active, enrolled Phase 2 Last updated 22 July 2025

What this trial tests

Phase 2 trial testing Ipilimumab 200 MG in 40 ML Injection in Metastatic Cancer Colorectal in 57 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 December 2017

Primary endpoint
10 January 2020

1 December 2025

Quick facts

Lead sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	57
Start date	4 December 2017
Primary completion	10 January 2020
Estimated completion	1 December 2025
Sites	8 locations across France

Drugs / interventions tested

• Ipilimumab 200 MG in 40 ML Injection — full drug profile →
• Nivolumab 10 MG/ML — full drug profile →

Conditions studied

• Metastatic Cancer Colorectal — all drugs for Metastatic Cancer Colorectal →

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Who can join

18 and older, any sex, with Metastatic Cancer Colorectal. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease Control Rate (DCR)
  Time frame: At 12 weeks
  According with RECIST 1.1 and iRECIST

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
2. Immunotherapy efficacy on mismatch repair-deficient colorectal cancer: From bench to bedside.
   Lizardo DY, Kuang C, Hao S, Yu J, et al · · 2020 · cited 160× · PMID 33035640 · DOI 10.1016/j.bbcan.2020.188447
3. Predictive biomarkers of colon cancer immunotherapy: Present and future.
   Hou W, Yi C, Zhu H. · · 2022 · cited 100× · PMID 36483562 · DOI 10.3389/fimmu.2022.1032314
4. RECIST and iRECIST criteria for the evaluation of nivolumab plus ipilimumab in patients with microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: the GERCOR NIPICOL phase II study.
   Cohen R, Bennouna J, Meurisse A, Tournigand C, et al · · 2020 · cited 60× · PMID 33148693 · DOI 10.1136/jitc-2020-001499
5. Immunotherapy for Colorectal Cancer with High Microsatellite Instability: The Ongoing Search for Biomarkers.
   Ros J, Baraibar I, Saoudi N, Rodriguez M, et al · · 2023 · cited 40× · PMID 37686520 · DOI 10.3390/cancers15174245
6. Immune checkpoint inhibitors in colorectal cancer: limitation and challenges.
   Yan S, Wang W, Feng Z, Xue J, et al · · 2024 · cited 34× · PMID 38919624 · DOI 10.3389/fimmu.2024.1403533
7. Prediction of response to immune checkpoint blockade in patients with metastatic colorectal cancer with microsatellite instability.
   Ratovomanana T, Nicolle R, Cohen R, Diehl A, et al · · 2023 · cited 34× · PMID 37269904 · DOI 10.1016/j.annonc.2023.05.010
8. Microsatellite Instability: From the Implementation of the Detection to a Prognostic and Predictive Role in Cancers.
   Amato M, Franco R, Facchini G, Addeo R, et al · · 2022 · cited 32× · PMID 35955855 · DOI 10.3390/ijms23158726