NCT03353831

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: AGO Research GmbH · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period
DRUG	Atezolizumab	Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period
DRUG	Chemotherapy	Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28
DRUG	Placebos	Placebo will be administered by intravenous route q14 during the treatment period

Timeline

• Start date: 2018-09-11
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2017-11-27
• Last updated: 2025-04-06

Locations

111 sites across 12 countries: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Lithuania, Norway, Spain, Sweden, Switzerland