再発子宮がん患者における治験療法または化学療法の抗がん効果に関する臨床研究 (Fern-EC-01)
HER2 発現再発子宮内膜がん患者における、BNT323/DB-1303 と治験責任医師の選択による化学療法の第 III 相無作為化多部位非盲検試験
The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel [or docetaxel, if participants cannot take paclitaxel]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).
In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.
The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.
調査の概要
詳細な説明
This is an open-label, randomized, multi-site, Phase III, interventional clinical study designed to determine the efficacy and safety of BNT323 compared with investigator's choice of single agent chemotherapy in previously treated participants with recurrent endometrial cancer (including HER2 1+ or 2+ score as determined using a centralized immunohistochemistry [IHC] analysis method), whose disease has progressed on at least one line of platinum-based therapy and ICI (Cohort 1). In addition, participants with recurrent endometrial cancer with HER2 IHC 3+ score will be enrolled in a BNT323 monotherapy arm (Cohort 2) to further investigate the efficacy and safety of BNT323.
In Cohort 1, participants will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy, preferably doxorubicin or paclitaxel (or docetaxel if contraindicated to paclitaxel and available at the site) until Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) defined progressive disease (PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
In Cohort 2, participants will receive BNT323 monotherapy until RECIST v1.1 defined PD unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
The study consists of a screening period, a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. The expected treatment duration per participant is ~6 months, followed by an anticipated long-term survival follow-up period of up to 53 months.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：BioNTech clinical trials patient information
- 電話番号：+49 6131 9084
- メール：patients@biontech.de
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90033
- 募集
- USC/Norris Cancer Center
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- 募集
- University of Colorado Cancer Center
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06520
- 募集
- Yale University School of Medicine
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- 募集
- MedStar Washington Hospital Center
-
-
Florida
-
Fort Lauderdale、Florida、アメリカ、33316
- 募集
- Broward Health Medical Center
-
-
Illinois
-
Peoria、Illinois、アメリカ、61637
- 募集
- OSF Saint Francis Medical Center
-
Urbana、Illinois、アメリカ、61801
- 募集
- Carle Cancer Institute
-
-
Kentucky
-
Lexington、Kentucky、アメリカ、40503
- 募集
- Baptist Health Lexington
-
-
Louisiana
-
Shreveport、Louisiana、アメリカ、71103
- 募集
- WK Cancer Center
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- 募集
- Minnesota Oncology
-
-
Nevada
-
Reno、Nevada、アメリカ、89511
- 募集
- The Center of Hope Reno
-
-
New York
-
Mineola、New York、アメリカ、11501
- 募集
- NYU Langone Hospital - Long Island
-
New York、New York、アメリカ、10016
- 募集
- NYU Langone Health
-
Syracuse、New York、アメリカ、13210
- 募集
- SUNY Upstate Medical University
-
-
Ohio
-
Centerville、Ohio、アメリカ、45459
- 募集
- Miami Valley Hospital South
-
Hilliard、Ohio、アメリカ、43026
- 募集
- Ohio State University
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- 募集
- Peggy & Charles Stephenson Oklahoma Cancer Center
-
-
Pennsylvania
-
Willow Grove、Pennsylvania、アメリカ、19090
- 募集
- Asplundh Cancer Pavilion
-
-
South Dakota
-
Sioux Falls、South Dakota、アメリカ、57104
- 募集
- Sanford Cancer Center
-
-
Texas
-
Tyler、Texas、アメリカ、75702
- 募集
- Texas Oncology, P.A.
-
-
Utah
-
Murray、Utah、アメリカ、84107-5701
- 募集
- Intermountain Healthcare
-
-
Virginia
-
Norfolk、Virginia、アメリカ、23502
- 募集
- Virginia Oncology Associates
-
-
-
-
-
Buenos Aires、アルゼンチン、C1280AEB
- 募集
- Hospital Británico de Buenos Aires
-
Buenos Aires、アルゼンチン、01426
- 募集
- Centro de Oncologia Dr. Doreski - Fundación Respirar
-
Buenos Aires、アルゼンチン、B7600FYK
- 募集
- Centro de Investigaciones Medicas Mar del Plata
-
Córdoba、アルゼンチン、X5008AAC
- 募集
- CEMAIC - Centro Medico Privado
-
La Rioja、アルゼンチン、F5300COE
- 募集
- Investigaciones CORI S.R.L.
-
Mendoza、アルゼンチン、M5500AYB
- 募集
- COIR Fundacion Centro Oncologi, de Integracion Regional
-
Mendoza、アルゼンチン、M5500
- 募集
- Fundación Oncológica Mendoza
-
Rosario、アルゼンチン、S2002KDS
- 募集
- Hospital Provincial del Centenario
-
San Juan、アルゼンチン、5400
- 募集
- Centro Oncológico de Excelencia
-
San Miguel de Tucumán、アルゼンチン、4000
- 募集
- Clinica Mayo de Urgencias
-
-
-
-
-
Brighton、イギリス、BN2 1ES
- 募集
- Royal Sussex County Hospital
-
Bristol、イギリス、BS2 8ED
- 募集
- Bristol Haematology and Oncology Centre
-
Cambridge、イギリス、CB2 0QQ
- 募集
- Addenbrooke's Hospital
-
Cottingham、イギリス、HU165JQ
- 募集
- Castle Hill Hospital
-
Coventry、イギリス、CV2 2DX
- 募集
- Warwick Hospital
-
Edinburgh、イギリス、EH4 2XU
- 募集
- Western General Hospital
-
Exeter、イギリス、EX2 5DW
- 募集
- Royal Devon & Exeter HPT
-
London、イギリス、SE1 9RT
- 募集
- Guy's Hospital
-
London、イギリス、NW1 2PG
- 募集
- University College London Hospitals
-
Middlesex、イギリス、HA6 2RN
- 募集
- Mount Vermont Cancer Center
-
Nottingham、イギリス、NG5 1PB
- 募集
- Nottingham University Hospitals NHS Trust
-
Swansea、イギリス、SA2 8QA
- 募集
- Singleton Hospital
-
Truro、イギリス、TR1 3LJ
- 募集
- Royal Cornwall Hospital
-
-
-
-
-
Hadera、イスラエル、382302
- 募集
- Hillel Yaffe Medical Center
-
Haifa、イスラエル、3436212
- 募集
- Lady Davis Carmel Medical Center
-
Jerusalem、イスラエル、9103102
- 募集
- Shaare Zedek Medical Center
-
Jerusalem、イスラエル、9112001
- 募集
- Hadassah Ein Kerem Medical Center
-
Jerusalem、イスラエル、9103102
- 募集
- Shaare Zedek
-
Petah Tikva、イスラエル、4941492
- 募集
- Rabin Medical Center-Beilinson Campus
-
Ramat Gan、イスラエル、5265601
- 募集
- Sheba Medical Center
-
Tel Aviv、イスラエル、642390
- 募集
- Sourasky Medical Centre
-
-
-
-
-
Bari、イタリア、70124
- 募集
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
-
Bologna、イタリア、40138
- 募集
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
-
Catania、イタリア、95126
- 募集
- Azienda Ospedaliera Cannizzaro - Oncologia
-
Meldola、イタリア、47014
- 募集
- IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST)
-
Milan、イタリア、20132
- 募集
- Ospedale San Raffaele
-
Milan、イタリア、20133
- 募集
- Istituto Nazionale dei Tumori
-
Milan、イタリア、20141
- 募集
- Istituto Europeo di Oncologia
-
Milan、イタリア、20159
- 募集
- Humanitas San Pio X
-
Naples、イタリア、80131
- 募集
- Istituto Nazionale Tumori Fondazione G. Pascale
-
Roma、イタリア、00168
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Torino、イタリア、10128
- 募集
- Azienda Ospedaliera Ordine Mauriziano Umberto I di Torino
-
-
-
-
-
Nijmegen、オランダ、6525 GA
- 募集
- Radboud UMC
-
Rotterdam、オランダ、3015 AA
- 募集
- Erasmus Medisch Centrum
-
-
-
-
-
Adelaide、オーストラリア、5000
- 募集
- Cancer Research SA
-
Adelaide、オーストラリア、5000
- 募集
- Adelaide Oncology & Haematology
-
Clayton、オーストラリア、3168
- 募集
- Monash Health Clinical Trial Center
-
Gosford、オーストラリア、2250
- 募集
- Gosford Hospital
-
Melbourne、オーストラリア、3000
- 募集
- Peter MacCallum Cancer Centre
-
Melbourne、オーストラリア、VIC 3199
- 募集
- Frankston Hospital
-
Nowra、オーストラリア、2541
- 募集
- Shoalhaven Cancer Care Centre
-
Saint Albans、オーストラリア、3021
- 募集
- Sunshine Hospital
-
South Brisbane、オーストラリア、4001
- 募集
- Mater Hospital Brisbane
-
Wollongong、オーストラリア、2500
- 募集
- Wollongong Hospital
-
-
-
-
-
Innsbruck、オーストリア、6020
- 募集
- Medizinische Universität Innsbruck
-
Vienna、オーストリア、A-1090
- 募集
- Medical University of Vienna
-
-
-
-
-
Montreal、カナダ、H3T 1E2
- 募集
- Jewish General Hospital
-
St. John's、カナダ、A1V 3V6
- 募集
- Health Sciences Centre
-
Toronto、カナダ、M5G 2M9
- 募集
- Princess Margaret Cancer C
-
-
-
-
-
Athens、ギリシャ、11528
- 募集
- Alexandra General Hospital of Athens
-
Athens、ギリシャ、11528
- 募集
- Aretaieio Hospital
-
Chaïdári、ギリシャ、124 62
- 募集
- University General Hospital Attikon
-
Kalamata、ギリシャ、24100
- 募集
- General Hospital of Kalamata
-
Marousi、ギリシャ、151 23
- 募集
- IASO General Clinic
-
-
-
-
-
Singapore、シンガポール、168583
- 募集
- National Cancer Centre Singapore
-
Singapore、シンガポール、258499
- 募集
- OncoCare Cancer Centre
-
-
-
-
-
Lund、スウェーデン、222 42
- 募集
- Skånes Universitetssjukhus Lund
-
Stockholm、スウェーデン、17176
- 募集
- Karolinska University Hospital
-
Uppsala、スウェーデン、75185
- 募集
- Akademiska Sjukhuset
-
-
-
-
-
A Coruña、スペイン、15006
- 募集
- Complejo Hospitalario Universitario A Coruña
-
Barcelona、スペイン、08036
- 募集
- Hospital Clinic de Barcelona
-
Barcelona、スペイン、08035
- 募集
- Hospital Universitari Vall, d'Hebron
-
Córdoba、スペイン、14004
- 募集
- Hospital Universitario Reina Sofia
-
Donostia / San Sebastian、スペイン、20014
- 募集
- Hospital Universitar Donostia
-
Girona、スペイン、17007
- 募集
- Institut Català d'Oncologia (ICO) Hospital Universitari de Girona Dr. Josep Trueta
-
Jaén、スペイン、23007
- 募集
- Hospital Universitario de Jaén
-
Madrid、スペイン、28041
- 募集
- Hospital Universitario 12 de Octubre
-
Madrid、スペイン、28046
- 募集
- Hospital Universitario La Paz
-
Madrid、スペイン、28034
- 募集
- Hospital Universitario Ramón y Cajal
-
Palma de Mallorca、スペイン、07120
- 募集
- Hospital Universit Son Espases
-
Valencia、スペイン、46009
- 募集
- Instituto Valenciano de Oncología - Valencia
-
Valencia、スペイン、46026
- 募集
- Hospital Univers Politec La Fe
-
-
-
-
-
Brno、チェコ、60200
- 募集
- Gynekologicko-porodnická klinika, Fakultni nemocnice Brno
-
Olomouc、チェコ、77900
- 募集
- University Hospital Olomouc - Onkologická klinika- Fakultni
-
Ostrava、チェコ、01790
- 募集
- Fakultní nemocnice Ostrava
-
Prague、チェコ、12808
- 募集
- Vseobecna fakultni nemocnice v Praze
-
Prague、チェコ、15000
- 募集
- Fakultní nemocnice Motol a Homolka
-
Prague、チェコ、18081
- 募集
- Fakultní nemocnice Bulovka
-
-
-
-
-
Aalborg、デンマーク、9000
- 募集
- Aalborg Universit Hospital
-
Copenhagen、デンマーク、2100
- 募集
- Rigshospitalet
-
Herlev、デンマーク、2730
- 募集
- Herlev og Gentofte Hospital
-
Odense、デンマーク、5000
- 募集
- Odense University Hospital
-
-
-
-
-
Adana、トルコ（Türkiye）、01120
- 募集
- Baskent University Adana Application and Research Center
-
Ankara、トルコ（Türkiye）、06490
- 募集
- Baskent University Ankara Hospital
-
Ankara、トルコ（Türkiye）、06200
- 募集
- Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
-
Ankara、トルコ（Türkiye）、06230
- 募集
- Hacettepe University
-
Bayraklı、トルコ（Türkiye）、35540
- 募集
- İzmir City Hospital
-
Istanbul、トルコ（Türkiye）、34093
- 募集
- Istanbul University Istanbul Medical Faculty
-
Istanbul、トルコ（Türkiye）、34093
- 募集
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Berlin、ドイツ、13353
- 募集
- Charité - Campus Virchow-Klinikum
-
Essen、ドイツ、45136
- 募集
- Kliniken Essen-Mitte
-
Kassel、ドイツ、34125
- 募集
- Klinkum Kassel
-
München、ドイツ、81377
- 募集
- LMU-Campus Innenstadt
-
Tübingen、ドイツ、72076
- 募集
- Universitaets-Frauenklinik, Tübingen
-
-
-
-
-
Oslo、ノルウェー、0379
- 募集
- Oslo University Hospital
-
Stavanger、ノルウェー、4011
- 募集
- Stavanger University Hospital
-
-
-
-
-
Budapest、ハンガリー、1088
- 募集
- Semmelweis Egyetem
-
Budapest、ハンガリー、1122
- 募集
- Országos Onkológiai Intézet
-
Debrecen、ハンガリー、4032
- 募集
- Debreceni Egyetem
-
Kecskemét、ハンガリー、6000
- 募集
- Bács-Kiskun Vármegyei Oktatókórház
-
Zalaegerszeg、ハンガリー、8900
- 募集
- Zala Varmegyei Szent Rafael Korhaz
-
-
-
-
-
Kuopio、フィンランド、70210
- 募集
- Kuopio University HPT
-
Oulu、フィンランド、90029
- 募集
- OYS Naisten poliklinikka
-
Turku、フィンランド、20521
- 募集
- Turun yliopistollinen keskussairaala
-
-
-
-
-
Angers、フランス、49055
- 募集
- ICO - Site Paul Papin
-
Besançon、フランス、25000
- 募集
- CHU Besançon Service Oncologie
-
Caen、フランス、14000
- 募集
- Centre François Baclesse
-
Le Mans、フランス、72000
- 募集
- Clinique Victor Hugo - Centre Jean Bernard
-
Marseille、フランス、13015
- 募集
- Hôpital Nord Bâtiment Mistral
-
Paris、フランス、75010
- 募集
- Hôpital Saint Louis
-
Saint-Herblain、フランス、44800
- 募集
- ICO - Site René Gauducheau
-
Strasbourg、フランス、67000
- 募集
- Institut de Cancérologie de Strasbourg Europe - ICANS
-
Vandœuvre-lès-Nancy、フランス、54519
- 募集
- Institut de Cancérologie de Lorraine
-
-
-
-
-
Ipatinga、ブラジル、35162-189
- 募集
- Fundação Sao Francisco Xavier
-
Passo Fundo、ブラジル、99010-260
- 募集
- Hospital de Clínicas de Passo Fundo
-
Porto Alegre、ブラジル、90050-170
- 募集
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
-
Porto Alegre、ブラジル、90035-000
- 募集
- Instituto de Pesquisa Clínica - Hospital Moinhos de Vento
-
Porto Alegre、ブラジル、90610-000
- 募集
- HPT São Lucas da PUCRS - UBEA
-
Porto Alegre、ブラジル、90035-903
- 募集
- Hospital de Clínicas de Porto Alegre
-
São José do Rio Preto、ブラジル、15090-000
- 募集
- Fundação Faculdade Regional de Medicina de São José do Rio Petro
-
São Paulo、ブラジル、01308-050
- 募集
- Hospital Sirio Libanês
-
São Paulo、ブラジル、01401-002
- 募集
- Inst D'Or de Pesquisa E Ensino
-
-
-
-
-
Brussels、ベルギー、1070
- 募集
- Institut Jules Bordet
-
Brussels、ベルギー、1200
- 募集
- Cliniques Universitaires Saint-Luc
-
Edegem、ベルギー、2650
- 募集
- Universitair Ziekenhuis Antwerpen (UZA)
-
Ghent、ベルギー、9000
- 募集
- Universitair Ziekenhuis Gent
-
Ghent、ベルギー、9000
- 募集
- AZ Maria Middelares
-
Kortrijk、ベルギー、8500
- 募集
- AZ Groeninge VZW
-
Leuven、ベルギー、3000
- 募集
- UZ Leuven
-
Liège、ベルギー、4000
- 募集
- Centre Hospitalier Universitaire de Liège
-
Namur、ベルギー、B5000
- 募集
- CHU UCL Namur-Sainte-Elisabeth
-
-
-
-
-
Bialystok、ポーランド、15-027
- 募集
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie
-
Poznan、ポーランド、60-569
- 募集
- Uniwersytecki Szpital Kliniczny w Poznaniu
-
Siedlce、ポーランド、08-110
- 募集
- Siedleckie Centrum Onkologii
-
-
-
-
-
Wuhan、中国、430048
- 募集
- Union Hospital
-
-
Anhui
-
Hefei、Anhui、中国、230001
- 募集
- Anhui Provincial Hospital
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- 募集
- Beijing Cancer Hospital
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400010
- 募集
- The Second Affiliated Hospital of Chongqing Medical University
-
-
Fujian
-
Fuzhou、Fujian、中国、350014
- 募集
- Fujian Provincial Cancer Hospital
-
Xiamen、Fujian、中国、361003
- 募集
- First Affiliated Hospital of Xiamen University
-
-
Gansu
-
Lanzhou、Gansu、中国、730050
- 募集
- Gansu Provincial Maternity and Child-care Hospital
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510080
- 募集
- The First Affiliated Hospital of Sun Yat-sen University
-
Shantou、Guangdong、中国、515063
- 募集
- Cancer Hospital of Shantou University Medical College
-
-
Guangxi
-
Nanning、Guangxi、中国、530200
- 募集
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150091
- 募集
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Henan、Henan、中国、450003
- 募集
- Henan Cancer Hospital
-
Zhengzhou、Henan、中国、450014
- 募集
- The Second Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- 募集
- Hubei Cancer Hospital
-
Xiangyang、Hubei、中国、441138
- 募集
- Xiangyang Central Hospital
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210008
- 募集
- The Affiliated Hospital of Nanjing University Medical School
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330006
- 募集
- Jiangxi Maternal and Child Health Hospital
-
-
Jilin
-
Changchun、Jilin、中国、130021
- 募集
- The First Hospital of Jilin University
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710061
- 募集
- The First Affiliated Hospital of Xian Jiaotong University
-
-
Shandong
-
Jinan、Shandong、中国、250117
- 募集
- Cancer Hospital of Shandong First Medical University
-
Jining、Shandong、中国、272029
- 募集
- Affiliated Hospital of Jining Medical University
-
Linyi、Shandong、中国、276001
- 募集
- Linyi Cancer Hospital
-
Yantai、Shandong、中国、264000
- 募集
- Yantai Yuhuangding Hospital
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200032
- 募集
- Fudan University Shanghai Cancer Center
-
Shanghai、Shanghai Municipality、中国、200011
- 募集
- Obstetrics & Gynecology Hospital of Fudan University
-
-
Sichuan
-
Chengdu、Sichuan、中国、610072
- 募集
- Sichuan Provincial People's Hospital
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- 募集
- Tianjin Medical University Cancer Institute & Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- 募集
- Zhejiang Cancer Hospital
-
Wenzhou、Zhejiang、中国、325015
- 募集
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
-
Taichung、台湾、40705
- 募集
- Taichung Veterans General Hospital
-
Taichung、台湾、40447
- 募集
- China Medical University Hospital
-
Taichung、台湾、433004
- 募集
- Kuang Tien General Hospital
-
Tainan、台湾、70457
- 募集
- National Cheng Kung University Hospital
-
Taipei、台湾、11217
- 募集
- Taipei Veterans General Hospital
-
Taipei、台湾、10449
- 募集
- MacKay Memorial Hospital_ Taipei Branch
-
-
-
-
-
Changwon、韓国、51353
- 募集
- Samsung Changwon Hospital
-
Daegu、韓国、42601
- 募集
- Keimyung Univty Dongsan Hospital
-
Goyang、韓国、10408
- 募集
- National Cancer Center
-
Seongnam、韓国、13620
- 募集
- Seoul National University Bundang Hospital
-
Seongnam-si、韓国、13496
- 募集
- CHA Bundang Medical Center
-
Seoul、韓国、05505
- 募集
- Asan Medical Center
-
Seoul、韓国、03080
- 募集
- Seoul National University Hospital
-
Seoul、韓国、03722
- 募集
- Severance Hospital, Yonsei University Health System
-
Seoul、韓国、06351
- 募集
- Samsung Medical Center
-
Seoul、韓国、02841
- 募集
- Korea University Anam Hospital
-
Seoul、韓国、06591
- 募集
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Seoul、韓国、07804
- 募集
- Ewha Womans University Seoul Hospital
-
Seoul、韓国、06273
- 募集
- Gangnam Severance Hospital, Yonsei University Health System
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Key Inclusion Criteria:
-
Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).
-
Have histologically confirmed endometrial cancer that:
- Is recurrent,
- Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and
- Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
-
Have measurable disease defined by RECIST v1.1.
-
Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
-
Have recurrent endometrial cancer and meet any of the following:
- developed recurrence <12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or
- developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting.
-
Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)
-
Have a life expectancy of ≥12 weeks at screening.
Key Exclusion Criteria:
- Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.
- Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.
- Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.
- Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
- Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.
- Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.
- Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.
- Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.
- Had prior treatment with topoisomerase I inhibitors, including ADCs.
- Have left ventricular ejection fraction <55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio >15.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：コホート1（HER2 IHCスコア1+または2+）：BNT323/DB-1303
|
intravenous (IV) infusion
他の名前：
|
|
実験的：コホート2（HER2 IHCスコア3+）- BNT323/DB-1303
|
intravenous (IV) infusion
他の名前：
|
|
アクティブコンパレータ：Cohort 1 - Doxorubicin or paclitaxel (or docetaxel)
Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site). |
IV infusion IV infusion IV bolus or infusion |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
コホート2：HER2 IHC 3+再発性子宮内膜癌患者における、治療中に発生した有害事象（TEAE）により、薬剤中断、用量減量、または研究治療中止を要した患者の割合
時間枠：研究治療の最終投与後最大35日間
|
研究治療の最終投与後最大35日間
|
|
|
Cohort 1: Overall survival (OS) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to death from any cause. |
Up to approximately 53 months
|
|
Cohort 1: PFS assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the time from randomization to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: ORR assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 1: ORR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the proportion of participants with a CR or PR (per RECIST v1.1) as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 1: Duration of response (DoR) assessed by BICR in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: DoR assessed by the investigator in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
By treatment arm. Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of treatment-emergent adverse events (TEAEs)
時間枠：Up to 35 days after the last dose of study treatment
|
By treatment arm. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. |
Up to 35 days after the last dose of study treatment
|
|
Cohort 1: Percentage of participants with HER2 IHC 1+/2+ recurrent endometrial cancer with occurrence of TEAEs leading to drug interruption, dose reduction, or discontinuation of study treatment.
時間枠：Up to 35 days after the last dose of study treatment
|
By treatment arm. |
Up to 35 days after the last dose of study treatment
|
|
Cohort 2: ORR assessed by the investigator participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the proportion of participants in whom a CR or PR (per RECIST v1.1) is observed as best overall response with confirmation. |
Up to approximately 53 months
|
|
Cohort 2: DoR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: DoR assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: PFS assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: PFS assessed by the investigator in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the time from the first dose of study treatment to the first objective tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first. |
Up to approximately 53 months
|
|
Cohort 2: OS in participants with HER2 IHC 3+ recurrent endometrial cancer
時間枠：Up to approximately 53 months
|
Defined as the time from the first dose of trial treatment to death from any cause. |
Up to approximately 53 months
|
|
Cohort 2: Percentage of participants with HER2 IHC 3+ recurrent endometrial cancer with occurrence of TEAEs
時間枠：Up to 35 days after the last dose of study treatment
|
BNT323 monotherapy. TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. |
Up to 35 days after the last dose of study treatment
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：BioNTech Responsible Person、BioNTech SE
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BNT323-01
- GOG-3105 (その他の識別子：Gynecologic Oncology Group Foundation)
- ENGOT- EN25/NSGO-CTU (その他の識別子：European Network for Gynaecological Oncological Trial and Nordic Society of Gynaecological Oncology Clinical Trial Unit)
- 2023 (米国 NIH グラント/契約)
- 2023-507525-42-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。