Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07679841
PHASE1/PHASE2

Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients

Sponsor: Centre Leon Berard

View on ClinicalTrials.gov

Summary

COLOMBE is a multicenter, single arm, phase 1/2 trial designed to evaluate the safety and efficacy of imiquimod cream with IV low dose nivolumab in primary resectable vulvar squamous cell carcinoma patients prior to surgery, leveraging the preoperative "window of opportunity" period, an unavoidable interval due to surgical scheduling.

Official title: A Multicentre, Single Arm, Phase 1/2 Study, Aiming to Assess the Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09

Completion Date

2029-09

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DRUG

Imiquimod 5% cream

At the starting dose (DL1) : 5 consecutive days per week for 4 weeks At DL-1: 3 consecutive days per week for 4 weeks

DRUG

Nivolumab

At DL1 and DL-1: Administration IV at a dose of 40 mg, every two weeks for 6 weeks (3 doses)

Locations (11)

CH de Bourg-en-Bresse

Bourg-en-Bresse, France

Centre Jean Perrin

Clermont-Ferrand, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

HCL - Centre Hospitalier Lyon Sud

Lyon, France

Hôpital Privé Jean Mermoz

Lyon, France

Institut Paoli-Calmettes

Marseille, France

CHU de Saint Etienne

Saint-Priest-en-Jarez, France

IUCT Oncopole Claudius Regaud

Toulouse, France