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Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

Recurrent Ovarian Carcinoma Clinical Trial

Official title:
Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial

Clinical Trial Summary

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to 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.

Clinical Trial Description

Approximately 550 patients will be randomized in a 1:1 ratio to the treatments as specified below: Arm A: Chemotherapy + Bevacizumab + Placebo Arm B: Chemotherapy + Bevacizumab + Atezolizumab Study treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, or patient or investigator decision to discontinue treatment. Atezolizumab/placebo, chemotherapy and bevacizumab may be discontinued for toxicity independently of each other in the absence of disease progression. For each patient, chemotherapy (PLD or Paclitaxel weekly) will be selected by the investigator prior to randomization. Recruitment to an individual chemotherapy cohort will be closed once 50% of patients are recruited to this cohort. In such case the remaining cohort will remain open for recruitment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03353831
Study type Interventional
Source AGO Research GmbH
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 11, 2018
Completion date December 1, 2024
View Details
See also
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