Abstract 880TiP
Background
Standard treatment for patients (pts) with locally advanced cervical cancer (LACC) is concurrent chemoradiotherapy (CCRT). Despite this therapeutic approach, pts with Stage III/IVA have a poor prognosis with a 5-year Overall Survival (OS) of 55% and even worse for pts with positive lymph nodes. These women are at greatest risk for recurrence and represent the population with the highest unmet need. Pembrolizumab and nivolumab, PD-1 inhibitors, have shown clinical activity in recurrent/metastatic cervical cancer. Moreover, pembrolizumab has been approved by FDA for pts with recurrent or metastatic cervical cancer who had progressed on or after platinum-based chemotherapy and whose tumours express CPS ≥1. Dostarlimab, an IgG4 humanized monoclonal antibody, binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. Studies in pts with advanced solid tumors showed clinical activity of dostarlimab and a favorable benefit risk profile. ATOMICC is a randomized, open-label, multicenter, phase II trial led by GEICO Group evaluating dostarlimab as maintenance therapy in women with LACC who achieved response after CCRT.
Trial design
Approximately 132 pts with high-risk (FIGO 2009 Stage IB2, IIA2, IIB with pelvic lymph node involvement, IIIA, IIIB, IVA or any FIGO stage with para-aortic lymph node involvement) histologically confirmed LACC who achieved a partial (PR) or complete response (CR) after CCRT will be recruited. Within the 12 weeks after CCRT, pts will be randomized 1:2 to either Arm A (control): no further treatment or arm B (experimental): maintenance treatment with dostarlimab 500 mg Q3W for the first 4 doses followed by 1000 mg Q6W thereafter up to 24 months, disease progression, unacceptable toxicity or withdrawal of consent. Randomization will be stratified according to: histology (squamous vs adenosquamous / adenocarcinoma), FIGO 2009 Stage and response to CCRT (CR vs PR). Primary endpoint is progression free survival by RECIST v1.1. Secondary endpoints are OS and quality of life. Severity of adverse events will be assessed by CTCAE vs 4.03. The study was open to recruitment in August 2019.
Clinical trial identification
EudraCT 2018-002155-15; NCT03833479.
Editorial acknowledgement
Juan Luis Sanz (APICES) for his editorial assistance.
Legal entity responsible for the study
GEICO (Grupo Español de Investigación en Cáncer de Ovario).
Funding
GSK/Tesaro.
Disclosure
M. Iglesias: Advisory/Consultancy: GSK Oncology; Advisory/Consultancy: Hoffmann-La Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD. G. Villacampa Javierre: Speaker Bureau/Expert testimony: Merck Sharp & Dohme. L. Gaba Garcia: Advisory/Consultancy: GSK/Tesaro; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: MSD. L.M. Manso: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodations: Tesaro; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodations: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodations: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer. I. Romero: Advisory/Consultancy: AstraZeneca Spain; Advisory/Consultancy: GSK/Tesaro Spain; Advisory/Consultancy: Clovis Spain; Advisory/Consultancy: Roche Spain. M.P. Barretina Ginesta: Advisory/Consultancy: GSK. G. Marquina: Advisory/Consultancy: PharmaMar; Advisory/Consultancy: Tesaro; Advisory/Consultancy: Clovis. A. González Martín: Advisory/Consultancy, Speaker Bureau/Expert testimony, Financial support for ANITA/GEICO trial: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony, Financial support for ANITA/GEICO trial: Tesaro; Advisory/Consultancy: Clovis; Advisory/Consultancy: Pfizer/Merck; Advisory/Consultancy: ImmunoGen; Advisory/Consultancy, Speaker Bureau/Expert testimony: PharmaMar; Advisory/Consultancy: MSD; Advisory/Consultancy: Genmab; Advisory/Consultancy: Oncoinvent; Leadership role, Chairman: GEICO (Grupo Español Investigación Cáncer de Ovario); Leadership role, Chairman: ENGOT (European Network for Gynecological Oncologic Trials). All other authors have declared no conflicts of interest.