NCT04256213

COL Immunotherapy Before Radiochimio + Ipilimumab

A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination with Ipilimumab (immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy

Detailed description

The aim of COLIBRI is to evaluate the evolution of the CD8+/FOXP3+ ratio of lymphocytes in pre- versus post-treatment biopsies in patients treated with a combination of Nivolumab and Ipilimumab in a pilot study, just before starting standard RT-CT. The study will also assess tolerability, Objective Response Rate, clinical activity and biological (dynamic) changes of the immune micro environment

Conditions

• Cervix Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab and Ipilimumab	Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)

Timeline

• Start date: 2020-07-02
• Primary completion: 2021-08-30
• Completion: 2024-08-04
• First posted: 2020-02-05
• Last updated: 2024-12-12

Locations

8 sites across 1 country: France