Spots Global Cancer Trial Database for Atezolizumab Trial in Endometrial Cancer - AtTEnd
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Trial Identification
Brief Title: Atezolizumab Trial in Endometrial Cancer - AtTEnd
Official Title: Phase III Double-blind Randomized Placebo Controlled Trial of Atezolizumab in Combination With Paclitaxel and Carboplatin in Women With Advanced/Recurrent Endometrial Cancer
Study ID: NCT03603184
Conditions
Study Description
Brief Summary: Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1. In May 2016 atezolizumab was approved by the FDA for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant); in October 2016 it was approved by the FDA for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Finally, in April 2017 atezolizumab was granted accelerated approval by FDA for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Combinations of atezolizumab with chemotherapeutic agents and/or targeted therapies were studied in different solid tumors such as melanoma, NSCLC, renal cell carcinoma and colorectal carcinoma. From these studies the AE profile of atezolizumab combinations were consistent with that of the individual agents. Finally, preliminary results of a Phase Ia study of Atezolizumab (NCT01375842) monotherapy in relapsed endometrial cancer were reported as abstract at ASCO 2017. Fifteen patients were evaluated for safety and efficacy with a minimum follow-up of 11.2 months. No G4-5 related AEs occurred. Regarding efficacy ORR was 13% \[2/15\] by RECIST. Atezolizumab seemed to have a favorable safety profile, with durable clinical benefit in some patients. Further studies with atezolizumab are warranted given its promising results in advanced endometrial cancer and the limited efficacy of current treatment options.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Royal Adelaide hospital, Adelaide, , Australia
Border Medical Oncology Research Unit, Albury, , Australia
Icon Cancer Centre, Auchenflower, , Australia
Pindara Private Hospital, Benowa, , Australia
Box Hill Hospital, Box Hill, , Australia
Frankston Hospital, Frankston, , Australia
Gosford Hospital, Gosford, , Australia
Royal Brisbane and Women's Hospital, Herston, , Australia
Royal Hobart Hospital, Hobart, , Australia
Liverpool Hospital, Liverpool, , Australia
Northern Cancer Institute, Saint Leonards, , Australia
Darling Downs Hospital and Health Service - Toowoomba Hospital, Toowoomba, , Australia
Calvary Mater Newcastle, Waratah, , Australia
Wollongong Hospital, Wollongong, , Australia
Medizinische Universitaet Graz - UniversitĂ€tsklinik fĂŒr Frauenheilkunde und Geburtshilfe, Graz, , Austria
Medical University of Innsbruck, Innsbruck, , Austria
Charité UniversitÀtsmedizin Berlin, Berlin, , Germany
Kliniken Essen Mitte, Essen, , Germany
UniversitÀtsKlinikum Heidelberg, Mannheim, , Germany
Klinikum der Ludwig-Maximilians-UniversitĂ€t MĂŒnchen (LMU), Muenchen, , Germany
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Policlinico S. Orsola Malpighi, Bologna, , Italy
Azienda Sanitaria dell'Alto Adige, Bolzano, , Italy
ASST degli Spedali Civili di Brescia, Brescia, , Italy
Fondazione Poliambulanza, Brescia, , Italy
AOU Cagliari, Policlinico Universitario, Cagliari, , Italy
AOU Careggi, Firenze, , Italy
ASST di Lecco, Lecco, , Italy
Ospedale San Luca, Lucca, , Italy
Istituto Europeo di Oncologia, Milan, , Italy
Ospedale San Gerardo, Monza, , Italy
Istituto Oncologico Veneto (IOV), Padova, , Italy
AOU di Parma, Parma, , Italy
AOU Pisana, Pisa, , Italy
AO Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Ausl Romagna, Rimini, , Italy
Policlinico Umberto I, UniversitĂ di Roma "La Sapienza", Roma, , Italy
Ospedale di Sondrio ASST Valtellina e Alto Lario, Sondrio, , Italy
Ospedale SS TrinitĂ , Sora, , Italy
AO Ordine Mauriziano, Torino, , Italy
AOU CittĂ della Salute e della Scienza di Torino - Ospedale Sant'Anna, Torino, , Italy
P.O Sant'Andrea Vercelli, Vercelli, , Italy
Hirosaki University Hospital, Aomori, , Japan
National Cancer Center Hospital East, Chiba, , Japan
Shikoku Cancer Center, Ehime, , Japan
Kurume University Hospital, Fukuoka, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
Tohoku University Hospital, Miyagi, , Japan
Niigata University MedicalïŒDental Hospital, Niigata, , Japan
Osaka University Hospital, Osaka, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
Keio University Hospital, Tokyo, , Japan
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Ilsan Cha Medical Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Konkuk University Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Auckland city Hospital, Auckland, , New Zealand
Hospital De Sant Pau I La Santa Creu, Barcelona, , Spain
Hospital Universitario Vall dÂŽHebron Institute of Oncology (VHIO), Barcelona, , Spain
Institut CatalĂ d'Oncologia (ICO) Girona, Girona, , Spain
Institut CatalĂ d'Oncologia (ICO), L'Hospitalet- Hospital Duran I Reynals, Hospitalet de Llobregat, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital ClĂnico Universitario Santiago de Compostela, Santiago De Compostela, , Spain
Hospital Universitario Miguel Servet Zaragoza, Zaragoza, , Spain
Kantonsspital, Baden, , Switzerland
UniversitÀtsspital, Basel, , Switzerland
IOSI, Bellinzona, , Switzerland
Inselspital, Bern, , Switzerland
Kantonsspital, Luzern, , Switzerland
Frauenfeld, MĂŒnsterlingen, , Switzerland
Kantonsspital, Winterthur, , Switzerland
UniversitĂ€tsspital, ZĂŒrich, , Switzerland
Chang Gung Memorial Hospital-Kaohsiung, Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital-Linkou, Taoyuan City, , Taiwan
Royal Derby Hospital, Derby, , United Kingdom
Royal Devon & Exeter Hospital, Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, , United Kingdom
Velindre Cancer Centre, Glasgow, , United Kingdom
Imperial College Healthcare NHS Trust, London, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
St Bartholomew's Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
NUHT - Nottingham University Hospital NHS Trust, Nottingham, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Contact Details
Name: Nicoletta Colombo, MD
Affiliation: Istituto Europeo di Oncologia (IEO) - Milan
Role: PRINCIPAL_INVESTIGATOR
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