A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab - ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE

ARCAGY-GINECO0 sites405 target enrollmentStarted: April 27, 2016Last updated: April 2, 2024

Overview

No summary available.

•I\-1\. Female Patients must be \=18 years of age.
•I\-2\. Signed informed consent and ability to comply with treatment and follow\-up.
•I\-3\. Patients with histologically confirmed non\-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian\-tube adenocarcinoma
•I\-4\. Patients with known PD\-L1 status on fresh mandatory biopsy sent to central laboratory as a formalin\-fixed, paraffin\-embedded (FFPE) sample.
•\- Cell pellet from pleural effusion, or ascites or lavage are not acceptable.
•\- For core needle biopsy specimens, at least two cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.
•I\-5\. Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:
•a) criterion for relapse can be according to RECIST v1\.1, CA125 (GCIG) or clinical symptoms
•b) 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.
•I\-6\. Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.

•E\-1\. Non\-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
•E\-2\. Ovarian tumors of low malignant potential (e.g. borderline tumors)
•E\-3\. Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
•a) stage \< II,
•b) 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.
•c) Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
•E\-4\. Other malignancy within the last 5 years except: adequately treated non\-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS).
•E\-5\. Patients receiving radiotherapy within 6 weeks prior to study treatment.
•E\-6\.Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery.
•E\-7\. Previous allogeneic bone marrow transplant or previous solid organ transplantation.

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