Project

Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer- a randomized Phase III trial An ENGOT Trial

Ongoing - recruitment active · 2021 until 2025

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Ongoing - recruitment active
Start Date
2021
End Date
2025
Financing
Others
Study Design
Phasse III
Homepage
Brief description/objective

This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared with placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum-based chemotherapy or 3rd relapse.

Despite optimal primary surgery and carboplatin/paclitaxel
based chemotherapy the majority of patients with advanced ovarian cancer will relapse. Treatment options for recurrent disease depend on treatment free interval, prior therapy, BRCAstatus, symptoms and patient wish. Further treatment depends on eligibility for platinum-based treatment. Randomized trials have shown efficacy of platinum retreatment in 1st and 2nd relapse. In patients, who are not eligible for another platinum-based treatment a non-platinum-based drug like PLD, gemcitabine, paclitaxel, or topotecan is the cytotoxic treatment of choice. The AURELIA trial showed a significant PFS benefit of adding bevacizumab to monochemotherapy in this patient
cohort (HR 0.48; 95%CI 0.38-0.60; p<0.001) (4). Therefore, bevacizumab based treatment is a new standard option in patients with platinum-resistant ovarian cancer.