Study population
NCT03298893
DISEASE, METASTATIC DISEASE, CERVICAL ADENOCARCINOMA
The NiCOL trial (NCT03298893) is an open-label, single-arm, phase-I, dose-confirmation, multicenter trial aiming to determine safety and tolerance, and immune correlates of concurrent and maintenance nivolumab plus CRT in LACC patients. Inclusion criteria included immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma or cervical squamous Federation of Gynecology and Obstetrics (FIGO) 2018 stages IB3-IVA, with an indication for curative intent cisplatin-based CRT. The disease had to be amenable to pretreatment biopsy. On-treatment biopsy was not allowed in the study. Exclusion criteria included distant metastatic disease, prior history of radiotherapy, systemic antineoplastic treatment, or clinically significant comorbidities. The Clermont-Ferrand ethic committee (CPP Sud-Est VI, AU 1316) approved the trial, which was conducted in accordance with the Declaration of Helsinki and the national regulatory requirements. All patients signed a written informed consent. The first patient was enrolled on 11/27/2017 and the last patient on 01/20/2020. An overview of the type of translational analyses performed and the number of datasets collected is shown in Supplementary Fig. 