Spots Global Cancer Trial Database for COL Immunotherapy Before Radiochimio + Ipilimumab
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Trial Identification
Brief Title: COL Immunotherapy Before Radiochimio + Ipilimumab
Official Title: 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
Study ID: NCT04256213
Conditions
Interventions
Study Description
Brief 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre François Baclesse, Caen, , France
Centre Léon Bérard, Lyon, , France
Groupe Hospitalier Diaconesses - Croix Saint-Simon, Paris, , France
Institut Curie, Paris, , France
Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA, Plérin, , France
Institut Jean Godinot, Reims, , France
Institut Claudius Regaud IUCT-O, Toulouse, , France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, , France
Contact Details
Name: Isabelle RAY-COQUARD, MD, PhD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
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