NCT02891824

ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 614 (actual)
• Sponsor: ARCAGY/ GINECO GROUP · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below: A. Arm A: Placebo + bevacizumab \& platinum-based chemotherapy. The placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization) 1. Carboplatin (day1)combined with gemcitabine (day1 \& day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or 2. Carboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or 3. Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + placebo ( day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression. B. Arm B: Atezolizumab + bevacizumab \& platinum-based chemotherapy The atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization) 1. Carboplatin (day1) combined with gemcitabine (day1 \& d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or 2. Carboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or 3. Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + atezolizumab (day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression. Before randomization to the study: * A tumor biopsy should have been obtained and sent to the central laboratory * PD-L1 status should be determined

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	atezolizumab + avastin + platinum-based chemotherapy	* atezolizumab will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression * avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression * platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles
DRUG	placebo + avastin + platinum-based chemotherapy	* placebo will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression * avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression * platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles

Timeline

• Start date: 2016-09-22
• Primary completion: 2021-10-15
• Completion: 2024-02-22
• First posted: 2016-09-08
• Last updated: 2025-02-11

Locations

75 sites across 7 countries: Austria, Belgium, Czechia, France, Germany, Israel, Spain