The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics. Other primary objective is to confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy.
This phase IV study will include two translational research projects: 1. The analyses of the circulating-tumor DNA (ctDNA) derived from plasma samples collected at different time points (liquid biopsy). This sub-study has the aim to evaluate and monitor, through the Next Generation Sequencing approach, the evolution of the disease and the changes in the mutational status of HR-related genes which could lead to different PARPi sensitivity (Translational study no.1). 2. The generation of organotypic models that include cancer stem cells to compare the response of these cancer stem cells to that of bulk tumor cells. This approach will be hopefully able to predict the response to PARPi in ovarian cancer patients. (Translational study no.2)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
190
Olaparib is considered the study treatment. Olaparib tablets will be taken at the dose of 300 mg (2 x 150 mg tablet) twice daily adding to bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks
Bevacizumab will be taken at a dose of 15 mg per kilogram of body weight every 3 weeks
Azienda Socio Sanitaria Territoriale (ASST) Lariana
San Fermo della Battaglia, Como, Italy
Spedali Civili
Brescia, Italy
Policlinico Careggi
Florence, Italy
Ospedale Manzoni
Lecco, Italy
Ospedale San Luca
Lucca, Italy
Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
AOU Parma
Parma, Italy
Ospedale Santa Chiara
Pisa, Italy
...and 4 more locations
Proportion of patients treated with olaparib
Define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib in combination with bevacizumab as maintenance and to describe their clinical and demographic characteristics
Time frame: 42 months
Efficacy of olaparib
Confirm, in a setting close to clinical practice, the efficacy of olaparib concomitant with bevacizumab as maintenance treatment after first-line chemotherapy in patients with advanced high grade EOC HRD-positive and who have received bevacizumab in combination with chemotherapy. The efficacy will be evaluated in terms of PFS rate at 24 months. PFS will be defined as the time from the start of olaparib therapy until disease progression or death whichever comes first
Time frame: 42 months
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