RT Journal Article SR Electronic T1 ATOMICC trial: a randomized, open-label, phase II trial of anti-PD1, dostarlimab, as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemoradiation JF International Journal of Gynecologic Cancer JO Int J Gynecol Cancer FD BMJ Publishing Group Ltd SP ijgc-2022-003370 DO 10.1136/ijgc-2022-003370 A1 Carmen Garcia-Duran A1 Francisco Grau A1 Guillermo Villacampa A1 Ana Oaknin YR 2022 UL http://ijgc.bmj.com/content/early/2022/04/20/ijgc-2022-003370.abstract AB Background Currently, women diagnosed with high-risk locally advanced cervical cancer are at high risk of recurrence after treatment with concurrent chemoradiation and represent a population with high unmet need.Primary Objective The primary objective is to evaluate the progression-free survival of high-risk locally advanced cervical cancer patients who have achieved a partial or complete response after chemoradiation after receiving dostarlimab as maintenance therapy.Study Hypothesis The study aims to demonstrate that the use of dostarlimab, as maintenance therapy, would significantly increase progression-free survival in these patients.Trial Design ATOMICC trial is a phase II, randomized, open-label, multicenter study to assess the efficacy and safety of anti-PD1, dostarlimab, as maintenance therapy in patients with high-risk locally advanced cervical cancer who have achieved a partial or complete response after chemoradiation. The control arm entails a clinical and radiological follow-up, with no further treatment (current standard of care). ATOMICC trial is an investigator-driven trial sponsored by GEICO (Grupo Español de Investigación en Cáncer de Ovario) and supported by GlaxoSmithKline (GSK).Major Inclusion/Exclusion Criteria Women aged over 18 years with a biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix meeting the following staging criteria: International Federation of Gynecology and Obstetrics (FIGO) 2009 stages IB2, IIA2, IIB with pelvic lymph node involvement, FIGO stages IIIA, IIIB, IVA, and any FIGO 2009 stage with para-aortic lymph node involvement are eligible for the trial. All patients must have achieved a partial or complete response after definitive concurrent chemoradiation. Women diagnosed with FIGO stage IVB, having undergone a previous hysterectomy, or having a history of active autoimmune disease will not be considered eligible.Primary Endpoint Progression-free survival defined as the time from the date of randomization to the date of first disease progression or death due to any cause, whichever occurs first.Sample Size A total of 132 patients are expected to be recruited in the study, using a 1:2 (control:experimental arm) randomization allocation ratio.Estimated Dates for Completing Accrual and Presenting Results The trial was launched in Q2-2019 and the trial is estimated to be closed for recruitment in Q3-2022. Results are expected to be released in Q3-2024.Trial Registration The trial is registered at ClinicalTrials.gov (NCT03833479).No data are available.