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ACTIVE NOT RECRUITING
NCT03556839
PHASE3

Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix

Sponsor: Grupo Español de Investigación en Cáncer de Ovario

View on ClinicalTrials.gov

Summary

The study will integrate the efficacy of combining the anti programmed death-ligand 1 (anti-PD-L1) agent atezolizumab with the current standard of care in Stage IVB , persistent or recurrent carcinoma of the cervix, namely cisplatin or carboplatin/paclitaxel/bevacizumab. It will be explored the combination of bevacizumab plus atezolizumab, with no patient selection based on PD-L1 expression, allowing an all-comer assessment of atezolizumab activity. The study is a randomized open label phase III trial to investigate the impact of atezolizumab in combination with bevacizumab and cisplatin or carboplatin /paclitaxel chemotherapy on overall survival and will employ the intent to treat principle, and random assignment to one of the 2 arms will be balanced according to disease histology (squamous cell carcinoma vs adenocarcinoma), prior platinum therapy as a radiation sensitizer (no prior cis-Radiotherapy (RT) versus prior cis-RT) and chemotherapy backbone (cisplatin vs carboplatin). This trial will be run in an open label design due to the following considerations: the control arm is the standard of care for women diagnosed with metastatic, persistant or recurrent cervical cancer because of its impact on overall survival and the primary endpoint of the study is overall survival (OS), so blinding is not needed to ensure a robust assessment.

Official title: A Randomized Phase III Trial of Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab Versus Platinum Chemotherapy Plus Paclitaxel and Bevacizumab in Metastatic (Stage IVB), Persistent, or Recurrent Carcinoma of the Cervix

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2018-09-25

Completion Date

2025-08

Last Updated

2025-01-08

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Intravenous Infusion

DRUG

Bevacizumab

Intravenous Infusion

DRUG

Cisplatin/Carboplatin

Intravenous Infusion

DRUG

Paclitaxel

Intravenous Infusion

Locations (72)

Willis Knighton Cancer Center

Shreveport, Louisiana, United States

Massey Cancer Center

Richmond, Virginia, United States

ICO Paul Papin

Angers, France

CHU Jean Minjoz

Besançon, France

Institut Bergonié

Bordeaux, France

Centre François Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

ICM Val d'Aurelle

Montpellier, France

Hôpital Privé du Confluent S.A.S.

Nantes, France

Centre Antoine Lacassagne

Nice, France

Groupe Hospitalier Diaconesses-Croix Saint-Simon

Paris, France

HEGP

Paris, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre CARIO-HPCA

Plérin, France

ICO Centre René Gauducheau

Saint-Herblain, France

Hôpitaux Universitaires

Strasbourg, France

Institut Claudius Régaud

Toulouse, France

Gustave Roussy

Villejuif, France

Universitätsmedizin Mainz

Mainz, Germany

Helios-Klinikum Wuppertal

Wuppertal, Germany

Fondazione Del Piemonte Per L'Oncologia

Candiolo, Italy

Azienda Ospedaliero-Universitaria Di Ferrara

Ferrara, Italy

Ospedale Lecce 'Vito Fazzi'

Lecce, Italy

ASST Lecco

Lecco, Italy

Irst Irccs

Meldola FC, Italy

Irccs S. Raffaele - Milano

Milan, Italy

Istituto Europeo di Oncologia

Milan, Italy

Ospedale San Gerardo

Monza, Italy

Istituto Nazionale Tumori Di Napoli Irccs Pascale

Naples, Italy

Istituto Oncologico Veneto (IOV) IRCCS

Padova, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

AUSL Romagna - P.O. di Ravenna, Lugo, Faenza, Rimini e Cattolica

Ravenna, Italy

Azienda Usl - Irccs Di Reggio Emilia

Reggio Emilia, Italy

Policlinico Universitario A. Gemelli

Roma, Italy

AOU Città della Salute e della Scienza di Torino, Presidio Sant'Anna

Torino, Italy

Ospedale Ordine Mauriziano

Torino, Italy

Azienda Sanitaria Universitaria Integrata Di Udine

Udine, Italy

Kurume University Hospital

Fukuoka, Japan

Saitama medical university international medical center

Hidaka, Japan

Hokkaido Cancer Center

Hokkaido, Japan

Hyogo Cancer Center

Hyōgo, Japan

Cancer Institute Hospital

Kōtoku, Japan

Niigata University Medical & Dental Hospital

Niigata, Japan

Shizuoka Cancer Center

Shizuoka, Japan

Keio University Hospital

Tokyo, Japan

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital

Oslo, Norway

University Hospital of North Norway

Tromsø, Norway

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Intitut Català d' Oncolgia L' Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Parc Taulí

Sabadell, Barcelona, Spain

Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital de la Vall d'Hebron

Barcelona, Spain

H. Clínic Barcelona

Barcelona, Spain

Hospital Reina Sofía Cordoba

Córdoba, Spain

ICO Girona

Girona, Spain

Hospital Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Complejo Hospitalario Regional de Málaga

Málaga, Spain

Hospital Clinico Universitario Virgen Arrixaca

Murcia, Spain

Hosptial Clinico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Virgen de la Salud

Toledo, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Quirón de Valencia

Valencia, Spain

Hospital Miguel Servet

Zaragoza, Spain

Lindköping University Hospital

Linköping, Sweden

Skane University Hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Uppsala University Hospital

Uppsala, Sweden