Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Trial Title: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

NCT ID: NCT04697628

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Gemcitabine
Irinotecan
Pemetrexed
Topotecan
Vinorelbine
Tisotumab vedotin

Conditions: Keywords:
Seattle Genetics

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: tisotumab vedotin
Description: 2.0 mg/kg every 3 weeks (Q3W)
Arm group label: Tisotumab vedotin

Other name: TIVDAK

Intervention type: Drug
Intervention name: topotecan
Description: 1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
Arm group label: Chemotherapy

Intervention type: Drug
Intervention name: vinorelbine
Description: 30 mg/m2 IV on Days 1 and 8, every 21 days
Arm group label: Chemotherapy

Intervention type: Drug
Intervention name: gemcitabine
Description: 1000 mg/m2 IV on Days 1 and 8, every 21 days
Arm group label: Chemotherapy

Intervention type: Drug
Intervention name: irinotecan
Description: 100 or 125 mg/m2 IV weekly for 28 days, every 42 days
Arm group label: Chemotherapy

Intervention type: Drug
Intervention name: pemetrexed
Description: 500 mg/m2 IV on Day 1, every 21 days
Arm group label: Chemotherapy

Summary: This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Criteria for eligibility:
Criteria:
Inclusion Criteria - Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: - Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: - paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or - paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent - Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required. - Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted. - Measurable disease according to RECIST v1.1 as assessed by the investigator. - Has ECOG performance status of 0 or 1 prior to randomization. - Has life expectancy of at least 3 months. Exclusion Criteria - Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above. - Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry. - Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed). - Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion. - Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration. - Peripheral neuropathy ≥grade 2. - Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham

Address:
City: Birmingham
Zip: 35294-3300
Country: United States

Facility:
Name: Arizona Oncology Associates, PC - HAL

Address:
City: Phoenix
Zip: 85016
Country: United States

Facility:
Name: Arizona Oncology Associates, PC - HOPE

Address:
City: Tucson
Zip: 85710
Country: United States

Facility:
Name: University of California Irvine Medical Center

Address:
City: Irvine
Zip: 92697
Country: United States

Facility:
Name: Olive View - UCLA Medical Center

Address:
City: Sylmar
Zip: 91342
Country: United States

Facility:
Name: Yale Cancer Center

Address:
City: New Haven
Zip: 06520
Country: United States

Facility:
Name: Broward Health Medical Center

Address:
City: Fort Lauderdale
Zip: 33316
Country: United States

Facility:
Name: Augusta University

Address:
City: Augusta
Zip: 30912
Country: United States

Facility:
Name: Northwestern Memorial Hospital

Address:
City: Chicago
Zip: 60611
Country: United States

Facility:
Name: Gynecological Cancer Institute of Chicago, LLC

Address:
City: Oak Lawn
Zip: 60453
Country: United States

Facility:
Name: Norton Cancer Institute

Address:
City: Louisville
Zip: 40207
Country: United States

Facility:
Name: Willis-Knighton Physician Network/Gynecologic Oncology Associates

Address:
City: Shreveport
Zip: 71103
Country: United States

Facility:
Name: Maryland Oncology Hematology, P.A.

Address:
City: Columbia
Zip: 21044
Country: United States

Facility:
Name: Minnesota Oncology Hematology P.A.

Address:
City: Minneapolis
Zip: 55404
Country: United States

Facility:
Name: St. Dominic - Jackson Memorial Hospital

Address:
City: Jackson
Zip: 39216
Country: United States

Facility:
Name: Washington University in St Louis

Address:
City: Saint Louis
Zip: 63108
Country: United States

Facility:
Name: Weill Cornell Medicine

Address:
City: Brooklyn
Zip: 11215
Country: United States

Facility:
Name: Weill Cornell Medicine

Address:
City: Flushing
Zip: 11355
Country: United States

Facility:
Name: New York University (NYU) Cancer Institute

Address:
City: New York
Zip: 10016
Country: United States

Facility:
Name: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Address:
City: Chapel Hill
Zip: 27599
Country: United States

Facility:
Name: Cleveland Clinic Fairview Hospital

Address:
City: Cleveland
Zip: 44111
Country: United States

Facility:
Name: Cleveland Clinic, The

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: Ohio State University Clinical Trials Management Office

Address:
City: Hilliard
Zip: 43026
Country: United States

Facility:
Name: Kettering Health

Address:
City: Kettering
Zip: 45429
Country: United States

Facility:
Name: Cleveland Clinic Hillcrest Hospital

Address:
City: Mayfield Heights
Zip: 44124
Country: United States

Facility:
Name: Oncology Associates of Oregon

Address:
City: Eugene
Zip: 97401
Country: United States

Facility:
Name: Northwest Cancer Specialists, P.C.

Address:
City: Portland
Zip: 97227
Country: United States

Facility:
Name: Texas Oncology - Austin Central

Address:
City: Austin
Zip: 78731
Country: United States

Facility:
Name: Texas Oncology - Fort Worth 12th Avenue

Address:
City: Fort Worth
Zip: 76104
Country: United States

Facility:
Name: Texas Oncology - The Woodlands

Address:
City: The Woodlands
Zip: 77380
Country: United States

Facility:
Name: Texas Oncology - Tyler

Address:
City: Tyler
Zip: 75702
Country: United States

Facility:
Name: University of Virginia

Address:
City: Charlottesville
Zip: 22901
Country: United States

Facility:
Name: Virginia Oncology Associates

Address:
City: Norfolk
Zip: 23502
Country: United States

Facility:
Name: Virginia Commonwealth University Medical Center

Address:
City: Richmond
Zip: 23219
Country: United States

Facility:
Name: Carbone Cancer Center / University of Wisconsin

Address:
City: Madison
Zip: 53792
Country: United States

Facility:
Name: Instituto Oncologico de Cordoba

Address:
City: Córdoba
Zip: X5006HBF
Country: Argentina

Facility:
Name: Fundacion Cenit

Address:
City: Caba
Zip: 1125
Country: Argentina

Facility:
Name: Instituto Alexander Fleming

Address:
City: Caba
Zip: 1426
Country: Argentina

Facility:
Name: Sanatorio de la Mujer

Address:
City: Rosario
Zip: 2000
Country: Argentina

Facility:
Name: LKH- Universitat Klinikum Graz

Address:
City: Graz
Zip: 8036
Country: Austria

Facility:
Name: AKH - Medizinische Universitat Wien

Address:
City: Vienna
Zip: 1090
Country: Austria

Facility:
Name: Institut Jules Bordet

Address:
City: Anderlecht
Zip: B-1070
Country: Belgium

Facility:
Name: ZNA Middelheim

Address:
City: Antwerpen
Zip: 2020
Country: Belgium

Facility:
Name: Cliniques Universitaires Saint Luc

Address:
City: Brussels
Zip: 1200
Country: Belgium

Facility:
Name: Universitair Ziekenhuis Gent

Address:
City: Gent
Zip: 9000
Country: Belgium

Facility:
Name: UZ Leuven campus Gasthuisberg

Address:
City: Leuven
Zip: 3000
Country: Belgium

Facility:
Name: CHU de Liege

Address:
City: Liege
Zip: 4000
Country: Belgium

Facility:
Name: CHU UCL Namur-Site de Saint Elisabeth

Address:
City: Namur
Zip: 5000
Country: Belgium

Facility:
Name: Grand Hopital de Charleroi

Address:
City: Charleroi
Zip: 6000
Country: Belgium

Facility:
Name: Erasto Gaertner Hospital

Address:
City: Curitiba
Zip: 81520-060
Country: Brazil

Facility:
Name: Hospital de Caridade de Ijui

Address:
City: Ijui
Zip: 98700-000
Country: Brazil

Facility:
Name: Hospital Mãe de Deus

Address:
City: Porto Alegre
Zip: 90110-270
Country: Brazil

Facility:
Name: Centro de Pesquisa em Oncologia - HSL-PUCRS

Address:
City: Porto Alegre
Zip: 90610-000
Country: Brazil

Facility:
Name: Brazilian National Cancer Institute

Address:
City: Rio de Janeiro
Zip: 20220---280
Country: Brazil

Facility:
Name: Hospital Beneficencia Portuguesa

Address:
City: Sao Paulo
Zip: 01323-001
Country: Brazil

Facility:
Name: Fundacao Antonio Prudente (AC Camargo Cancer Center)

Address:
City: Sao Paulo
Zip: 01509-010
Country: Brazil

Facility:
Name: Instituto Brasileiro de Controle do Cancer

Address:
City: Formosa
Zip: 73801-340
Country: Brazil

Facility:
Name: University of Alberta / Cross Cancer Institute

Address:
City: Edmonton
Zip: T6G 1Z2
Country: Canada

Facility:
Name: British Columbia Cancer Agency - Vancouver Centre

Address:
City: Vancouver
Zip: V5Z 4E6
Country: Canada

Facility:
Name: Sunnybrook Health Sciences Centre

Address:
City: Toronto
Zip: M4N 3M5
Country: Canada

Facility:
Name: University Health Network, Princess Margaret Hospital

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Centre Hospitalier de l'Universite de Montreal

Address:
City: Montreal
Zip: H2X 3E4
Country: Canada

Facility:
Name: Saskatoon Cancer Centre

Address:
City: Saskatoon
Zip: S7N 4H4
Country: Canada

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Facility:
Name: Beijing Obstetrics and Gynecology Hospital

Address:
City: Beijing
Zip: 100026
Country: China

Facility:
Name: Peking University People's Hospital

Address:
City: Beijing
Zip: 100044
Country: China

Facility:
Name: Jilin University - First Affiliated Hospital - Cancer Center

Address:
City: Changchun
Zip: 130000
Country: China

Facility:
Name: The Third Xiangya Hospital of Central South University

Address:
City: Changsha
Zip: 410008
Country: China

Facility:
Name: Hunan Cancer Hospital

Address:
City: Changsha
Zip: 410013
Country: China

Facility:
Name: Sichuan Cancer Hospital

Address:
City: Chengdu
Zip: 610041
Country: China

Facility:
Name: Chongqing Cancer Hospital

Address:
City: Chongqing
Zip: 400030
Country: China

Facility:
Name: The Second Hospital of Dalian Medical University

Address:
City: Dalian
Country: China

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou City
Zip: 510060
Country: China

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou City
Zip: 310022
Country: China

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Facility:
Name: Shanghai First People's Hospital

Address:
City: Shanghai
Zip: 200060
Country: China

Facility:
Name: Liaoning Cancer Hospital and Institute

Address:
City: Shenyang
Zip: 110042
Country: China

Facility:
Name: The Second Hospital of Hebei Medical University

Address:
City: Shijiazhuang
Zip: 050000
Country: China

Facility:
Name: The Second Hospital of Shanxi Medical University

Address:
City: Taiyuan
Zip: 030001
Country: China

Facility:
Name: Shanxi Province Cancer Hospital

Address:
City: Taiyuan
Zip: 30013
Country: China

Facility:
Name: The Affiliated Cancer Hospital of XinJiang Medical University

Address:
City: Urumqi
Zip: 830054
Country: China

Facility:
Name: The First Affiliated Hospital of Wenzhou Medical University

Address:
City: Wenzhou
Zip: 325000
Country: China

Facility:
Name: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Address:
City: Wuhan City
Zip: 430030
Country: China

Facility:
Name: Hubei Cancer Hospital

Address:
City: Wuhan
Zip: 430000
Country: China

Facility:
Name: Shaanxi Provincial People's Hospital

Address:
City: Xi'an
Zip: 710068
Country: China

Facility:
Name: The First Affiliated Hospital of Xinxiang Medical University

Address:
City: Xinxiang
Zip: 453700
Country: China

Facility:
Name: The Second People's Hospital of Yibin

Address:
City: Yibin
Zip: 644000
Country: China

Facility:
Name: Guangxi Medical University Affiliated Tumor Hospital

Address:
City: Nanning
Zip: 530021
Country: China

Facility:
Name: Fakultni nemocnice Brno

Address:
City: Brno-stred-Veveri
Zip: 602 00
Country: Czechia

Facility:
Name: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

Address:
City: Olomouc
Zip: 779 00
Country: Czechia

Facility:
Name: General University Hospital Prague

Address:
City: Praha 2
Zip: 120 00
Country: Czechia

Facility:
Name: Hospital Na Bulovce

Address:
City: Praha 8-Liben
Zip: 18081
Country: Czechia

Facility:
Name: Rigshospitalet

Address:
City: Kobenhavn
Zip: 2100
Country: Denmark

Facility:
Name: University of Turku

Address:
City: Turku
Zip: 20520
Country: Finland

Facility:
Name: Kuopio University Hospital

Address:
City: Kuopio
Zip: 70210
Country: Finland

Facility:
Name: Tampere University Hospital

Address:
City: Tampere
Zip: 33520
Country: Finland

Facility:
Name: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

Address:
City: Besancon Cedex
Zip: 25000
Country: France

Facility:
Name: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

Address:
City: Bordeaux
Zip: 33076
Country: France

Facility:
Name: Centre de Lutte contre le Cancer - Francois Baclesse

Address:
City: Caen Cedex 5
Zip: 14076
Country: France

Facility:
Name: CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie

Address:
City: Cotes d'Armor
Zip: 22190
Country: France

Facility:
Name: Institute Cancer De Lorraine (ICL) - Alexis Vautrin

Address:
City: Moselle
Zip: 54519
Country: France

Facility:
Name: Hopital Prive du Confluent

Address:
City: Nantes Cedex 2
Zip: 44277
Country: France

Facility:
Name: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon)

Address:
City: Paris
Zip: 75020
Country: France

Facility:
Name: Institut de cancerologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67200
Country: France

Facility:
Name: Institut Claudius Regaud IUCT-O

Address:
City: Toulouse Cedex 9
Zip: 31059
Country: France

Facility:
Name: Institut Gustave Roussy

Address:
City: Villejuif Cedex
Zip: 94805
Country: France

Facility:
Name: Kliniken Essen-Mitte

Address:
City: Essen
Zip: 45136
Country: Germany

Facility:
Name: Universitaetsklinikum Essen

Address:
City: Essen
Zip: 45147
Country: Germany

Facility:
Name: Universitaetsklinikum Hamburg-Eppendorf (UKE)

Address:
City: Hamburg
Zip: 20246
Country: Germany

Facility:
Name: University Hospital LMU Munich

Address:
City: Munchen
Zip: 81377
Country: Germany

Facility:
Name: National Institute of Oncology Hungary

Address:
City: Budapest, Pest
Zip: 1122
Country: Hungary

Facility:
Name: Medical and Health Science Centre Debrecen Institution of Internal Medicine

Address:
City: Debrecen, Hajdú-Bihar
Zip: 4032
Country: Hungary

Facility:
Name: Bacs-Kiskun Varmegyei Oktatokorhaz

Address:
City: Kecskemet
Zip: H6000
Country: Hungary

Facility:
Name: University Hospital Waterford

Address:
City: Waterford
Zip: X91 ER8E
Country: Ireland

Facility:
Name: Azienda Ospedaliera per l'Emergenza

Address:
City: Catania
Zip: 95126
Country: Italy

Facility:
Name: Ospedale San Raffaele

Address:
City: Milano
Zip: 20132
Country: Italy

Facility:
Name: Fondazione Policlinico Universitario Agostino

Address:
City: Roma
Zip: 00168
Country: Italy

Facility:
Name: Hospital San Bortolo

Address:
City: Vicenza
Zip: 36100
Country: Italy

Facility:
Name: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

Address:
City: Meldola
Zip: 47014
Country: Italy

Facility:
Name: National Cancer Center Hospital

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Facility:
Name: Kurume University Hospital

Address:
City: Fukuoka
Zip: 830-0011
Country: Japan

Facility:
Name: Gunma University Hospital

Address:
City: Gunma
Zip: 371-8511
Country: Japan

Facility:
Name: Saitama Cancer Center

Address:
City: Hidaka-City
Country: Japan

Facility:
Name: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Address:
City: Hiroshima
Zip: 737-0023
Country: Japan

Facility:
Name: Kagoshima University Hospital

Address:
City: Kagoshima City
Zip: 890-8520
Country: Japan

Facility:
Name: Kagoshima City Hospital

Address:
City: Kagoshima-City
Zip: 890-8760
Country: Japan

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Facility:
Name: The Jikei University Kashiwa Hospital

Address:
City: Kashiwashi
Zip: 277-8567
Country: Japan

Facility:
Name: Nippon Medical School Musashi Kosugi Hospital

Address:
City: Kawasaki
Zip: 211-8533
Country: Japan

Facility:
Name: NHO Shikoku Cancer Center

Address:
City: Matsuyama
Zip: 791-0280
Country: Japan

Facility:
Name: Aichi Cancer Center

Address:
City: Nagoya-shi
Zip: 464-8681
Country: Japan

Facility:
Name: University of the Ryukyus Hospital

Address:
City: Nakagami-gun
Zip: 903-0215
Country: Japan

Facility:
Name: Okayama University Hospital

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Facility:
Name: Kindai University Hospital

Address:
City: Osakasayama
Zip: 589-8511
Country: Japan

Facility:
Name: Osaka International Cancer Institute

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Facility:
Name: National Hospital Organization Hokkaido Cancer Center

Address:
City: Sapporo-shi
Zip: 003-0804
Country: Japan

Facility:
Name: Hokkaido University Hospital

Address:
City: Sapporo-shi
Country: Japan

Facility:
Name: Iwate Medical University Hospital

Address:
City: Shiwa-gun
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Sunto-Gun
Zip: 411-8777
Country: Japan

Facility:
Name: Jikei University Hospital

Address:
City: Tokyo
Zip: 105-0003
Country: Japan

Facility:
Name: The Cancer Institute Hospital of JFCR

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Keio University Hospital

Address:
City: Tokyo
Zip: 160-8582
Country: Japan

Facility:
Name: Yokohama City University Hospital

Address:
City: Yokohama
Zip: 232-0024
Country: Japan

Facility:
Name: Kanagawa Cancer Center

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi
Zip: 673-8558
Country: Japan

Facility:
Name: Ehime University Hospital

Address:
City: Ehime
Country: Japan

Facility:
Name: Niigata Cancer Center Hospital

Address:
City: Niigata
Zip: 951-8133
Country: Japan

Facility:
Name: Keimyung University Dongsan Medical Center

Address:
City: Daegu
Zip: 42601
Country: Korea, Republic of

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam-si
Zip: 13605
Country: Korea, Republic of

Facility:
Name: CHA Bundang Medical Center

Address:
City: Seongnam
Zip: 13496
Country: Korea, Republic of

Facility:
Name: Korea Cancer Center Hospital

Address:
City: Seoul
Zip: 01802
Country: Korea, Republic of

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Facility:
Name: Soon Chun Hyang University Hospital Seoul

Address:
City: Seoul
Zip: 04401
Country: Korea, Republic of

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Facility:
Name: Seoul Saint Mary's Hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Facility:
Name: Ewha Womans University Mokdong Hospital

Address:
City: Seoul
Zip: 07985
Country: Korea, Republic of

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 120-752
Country: Korea, Republic of

Facility:
Name: Inje University Busan-Paik Hospital

Address:
City: Busan
Zip: 47392
Country: Korea, Republic of

Facility:
Name: Sungkyunkwan University of Medicine - Samsung Changwon Hospital

Address:
City: Changwon, Kyungsangnam-do
Zip: 51353
Country: Korea, Republic of

Facility:
Name: Gangnam Severance Hospital

Address:
City: Seoul
Zip: 06273
Country: Korea, Republic of

Facility:
Name: Oncologico Potosino

Address:
City: San Luis Potosi
Zip: 78209
Country: Mexico

Facility:
Name: Amsterdam UMC, Locatie AMC

Address:
City: Amsterdam
Zip: 1081 HV
Country: Netherlands

Facility:
Name: Maastricht University Medical Center

Address:
City: Maastricht
Zip: 6229 HX
Country: Netherlands

Facility:
Name: Radboud University Medical Center

Address:
City: Nijmegen
Zip: 6525 GA
Country: Netherlands

Facility:
Name: Erasmus Medisch Centrum Daniel Den Hoed

Address:
City: Rotterdam
Zip: 3015GD
Country: Netherlands

Facility:
Name: Universitair Medisch Centrum Utrecht

Address:
City: Utrecht
Zip: 3584 CX
Country: Netherlands

Facility:
Name: Oslo University Hospital, Radiumhospitalet

Address:
City: Olso
Zip: 0379
Country: Norway

Facility:
Name: Trondheim University Hospital, Trondheim

Address:
City: Trondheim
Zip: 7030
Country: Norway

Facility:
Name: Hospital Maria Auxiliadora

Address:
City: Lima
Zip: 15081
Country: Peru

Facility:
Name: Białostockie Centrum Onkologii

Address:
City: Białystok
Zip: 15-027
Country: Poland

Facility:
Name: National University Cancer Institute, Singapore

Address:
City: Singapore
Zip: 119228
Country: Singapore

Facility:
Name: National Cancer Centre Singapore

Address:
City: Singapore
Zip: 169610
Country: Singapore

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Facility:
Name: Hospital Universitario Reina Sofia

Address:
City: Cordoba
Zip: 14004
Country: Spain

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Madrid
Zip: 28027
Country: Spain

Facility:
Name: Hospital Universitario 12 de Octubre

Address:
City: Madrid
Zip: 28041
Country: Spain

Facility:
Name: Hospital Universitario La Paz

Address:
City: Madrid
Zip: 28046
Country: Spain

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Facility:
Name: Hospital Clinico Universitario de Valencia

Address:
City: Valencia
Zip: 46010
Country: Spain

Facility:
Name: Linkoping University Hospital

Address:
City: Linköping
Zip: 581 85
Country: Sweden

Facility:
Name: Skanes University Hospital - Universitetssjukhus

Address:
City: Lund
Zip: 221 85
Country: Sweden

Facility:
Name: Uppsala University Hospital (Akademiska Sjukhuset)

Address:
City: Uppsala
Zip: 75185
Country: Sweden

Facility:
Name: Mackay Memorial Hospital

Address:
City: Taipei City
Zip: 10449
Country: Taiwan

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei City
Zip: 11217
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital - Linkou

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Facility:
Name: Cambridge University Hospitals NHS Foundation Trust

Address:
City: Cambridge
Zip: CB2 0QQ
Country: United Kingdom

Facility:
Name: Royal Devon and Exeter NHS Foundation Trust

Address:
City: Exeter
Zip: EX2 5DW
Country: United Kingdom

Facility:
Name: The Royal Marsden Hospital

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Facility:
Name: The Christie NHS Foundation Trust

Address:
City: Manchester
Zip: M20 4BX
Country: United Kingdom

Facility:
Name: The Royal Marsden Hospital (Surrey)

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Facility:
Name: The Beatson West of Scotland Cancer Centre

Address:
City: Glasgow
Zip: G12 0YN
Country: United Kingdom

Start date: February 22, 2021

Completion date: August 5, 2025

Lead sponsor:
Agency: Seagen Inc.
Agency class: Industry

Collaborator:
Agency: Genmab
Agency class: Industry

Source: Seagen Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT04697628