This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval \> 6 months).
Who can participate
Age range18 Years – 95 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female Patients must be ≥18 years of age.
✓. Signed informed consent and ability to comply with treatment and follow-up.
✓. Patients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma
✓. Patients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.
✓. Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:
✓. criterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms
✓. the interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.
✓. Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.
Exclusion criteria
✕. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
✕. Ovarian tumors of low malignant potential (e.g. borderline tumors)
✕. Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
What they're measuring
1
Efficacy: Progression free survival, where the date of progression is based on investigator assessment using the RECIST version 1.1
✕. Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1or 2 endometrioid adenocarcinoma.
✕. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
✕. Other malignancy within the last 5 years except cervix or breast in situ carcinoma, breast cancer ≥ 3 years free of disease and treatment, type I stage I endometrial cancer).
✕. Patients receiving radiotherapy within 6 weeks prior to study treatment.