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Platinum Chemotherapy Plus Paclitaxel With Bevacizumab and Atezolizumab in Metastatic Carcinoma of the Cervix
Sponsor: Grupo Español de Investigación en Cáncer de Ovario
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
Conditions
Interventions
Atezolizumab
Intravenous Infusion
Bevacizumab
Intravenous Infusion
Cisplatin/Carboplatin
Intravenous Infusion
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