Last updated on October 2017

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


Brief description of study

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 Study Description

Approximately 405 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

Clinical Study Identifier: NCT02891824

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Christian SCHAUER

Krankenhaus der Barmherzigen Br der Graz
Graz, Austria
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Edgar PETRU

Medical University of Graz
Graz, Austria
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Christian MARTH

Medical University of Innsbruck
Innsbruck, Austria
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Alexander REINTHALLER

Medical University of Vienna
Vienna, Austria
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Sophie ABADIE-LACOURTOISIE

ICO Paul Papin
Angers, France
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Julien GRENIER

Institut Sainte-Catherine
Avignon, France
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Elsa KALBACHER

CHRU Jean Minjoz
Besançon, France
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Nathalie BONICHON-LAMICHHANE

Clinique Tivoli
Bordeaux, France
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Anne FLOQUET

Institut Bergoni
Bordeaux, France
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Nadine DOHOLLOU

Polyclinique Bordeaux Nord
Bordeaux, France
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Florence JOLY

Centre Fran ois Baclesse
Caen, France
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Marie-Ange MOURET-REYNIER

Centre Jean Perrin
Clermont-Ferrand, France
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Hervé CURE

H pital Michallon - Centre Hospitalier Universitaire de Grenoble
Grenoble - La Tronche, France
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Laurence LANCRY-LECOMTE

Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
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Véronique GIRRE

Centre Hospitalier D partemental Les Oudairies
La Roche sur Yon, France
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Anne LESOIN

Centre Oscar Lambret
Lille, France
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Pierre-Etienne HEUDEL

Centre L on B rard
Lyon, France
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Renaud SABATIER

Institut Paoli Calmettes
Marseille, France
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Jérôme DAUBA

H pital de Mont-de-Marsan
Mont de Marsan, France
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Véronique D'HONDT

ICM Val d'Aurelle
Montpellier, France
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Rémy LARGILLIER

Centre Azur en de Canc rologie
Mougins, France
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Célia ROEMER-BECUWE

ORACLE - Centre d'Oncologie de Gentilly
Nancy, France
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Alain LORTHOLARY

H pital Priv du Confluent, S.A.S.
Nantes, France
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Philippe FOLLANA

Centre Antoine Lacassagne
Nice, France
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Miruna TIMAR-DAVID

CHU caremeau
Nimes, France
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Jérôme MEUNIER

Centre Hospitalier R gional d'Orl ans
Orléans, France
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Frédéric SELLE

Groupe Hospitalier Diaconesses-Croix Saint Simon
Paris, France
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Robert SVERDLIN

Groupe Hospitalier Saint-Joseph
Paris, France
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Jérôme ALEXANDRE

H pital Cochin
Paris, France
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Emilie BULTOT-BOISSIER

H pital Europ en Georges Pompidou
Paris, France
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Danièle AVENIN

H pital Tenon
Paris, France
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Manuel RODRIGUES

Institut Curie - Hopital Claudius R gaud
Paris, France
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Benoît YOU

Centre Hospitalier Lyon Sud
Pierre Bénite, France
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Anne-Claire HARDY-BESSARD

Centre CARIO - HPCA
Plérin sur Mer, France
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Nadia RABAN

H pital de la Mil trie - Centre Hospitalier Universitaire de Poitiers - P le R gional de Canc rologie
Poitiers, France
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Thibault DE LA MOTTE ROUGE

Centre Eug ne Marquis
Rennes, France
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Anne DONNADIEU

H pital Ren Huguenin, Institut Curie
Saint-Cloud, France
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Jean-Sébastien FRENEL

ICO Centre Ren Gauducheau
Saint-Herblain, France
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Thierry PETIT

Centre Paul Strauss
Strasbourg, France
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Jean-Emmanuel KURTZ

H pitaux Universitaires de Strasbourg
Strasbourg, France
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Raymond DESPAX

Clinique Pasteur - ONCOSUD
Toulouse, France
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Laurence GLADIEFF

Institut Claudius Regaud
Toulouse, France
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Marie-Christine KAMINSKY

ICL Institut de Canc rologie de Lorraine
Vandoeuvre Les Nancy, France
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Patricia PAUTIER

Gustave Roussy
Villejuif, France
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