Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

502

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

July 24, 2023

Study Completion Date

May 7, 2026

Conditions
Cervical Cancer
Interventions
DRUG

tisotumab vedotin

2.0 mg/kg every 3 weeks (Q3W)

DRUG

topotecan

1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days

DRUG

vinorelbine

30 mg/m2 IV on Days 1 and 8, every 21 days

DRUG

gemcitabine

1000 mg/m2 IV on Days 1 and 8, every 21 days

DRUG

irinotecan

100 or 125 mg/m2 IV weekly for 28 days, every 42 days

DRUG

pemetrexed

500 mg/m2 IV on Day 1, every 21 days

Trial Locations (217)

333

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital, Taoyuan District

1010

Radiologie - Diagnosezentrum Urania, Vienna

1070

Institut Jules Bordet, Anderlecht

1122

National Institute of Oncology,Department of Gynecology, Budapest

1200

Cliniques Universitaires Saint Luc, Brussels

2020

ZNA Middelheim, Antwerp

3000

UZ Leuven-Campus Gasthuisberg, Leuven

4000

CHU de Liege - Sart Tilman, Liège

4032

Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika, Debrecen

Debreceni Egyetem, Klinikai Kozpont, Orvosi Kepalkoto Klinika-Radiologia, Debrecen

Debreceni Egyetem, Klinikai Kozpont, Szemklinika, Debrecen

Scanomed Kft., Debrecen

5000

CHU UCL Namur-Site St-Elisabeth, Namur

6000

Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemét

9000

UZ Gent, Ghent

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone., New York

New York University (NYU) Cancer Institute, New York

NYU Langone Medical Center, New York

10408

National Cancer Center, Goyang-si

10449

Clinical Pharmacy, Mackay Memorial Hospital, Taipei

Mackay Memorial Hospital, Taipei

11215

NewYork Presbyterian - Brooklyn Methodist Hospital, Brooklyn

11355

NewYork Presbyterian - Queens, Flushing

11375

NewYork Presbyterian - Queens, Forest Hills

12000

Gynekologicko-porodnicka klinika 1. lekarske fakulty a Vseobecne fakultni nemocnice, Prague

13496

CHA Bundang Medical Cneter, CHA University, Seongnam-si

13620

Seoul National University Bundang Hospital, Seongnam-si

14004

Hospital Universitario Reina Sofia, Córdoba

15081

RCI 621 Hospital Maria Auxiliadora Unidad de investigacion en Oncologia, Lima

18081

Fakultni nemocnice Bulovka, Gynekologicko-porodnicka klinika, Praha 8-Liben

20132

Servizio di Farmacia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf (UKE), Hamburg

UKE, Universitatsklinikum Hamburg-Eppendorf, Hamburg

20520

Turku University Hospital, Lighthouse Hospital, Gynecology Outpatient Clinic, Turku

22190

Hopital Prive des Cotes d'Armor - Centre CARIO, Plérin

22903

University of Virginia Comprehensive Cancer Center, Charlottesville

22908

University of Virginia Health System, Charlottesville

23219

VCU Health- Adult Outpatient Pavilion, Richmond

Virginia Commonwealth University Medical Center, Richmond

23298

VCU Health, Investigational Drug Service (ATTN: Henly Deutsch, RPh), Richmond

Virginia Commonwealth University Massey Cancer Center, Richmond

25030

Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz, Besançon

28027

Clinica Universitaria de Navarra (sede Madrid), Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

30001

Second Hospital of Shanxi Medical University, Taiyuan

30013

The Shanxi Cancer Hospital, Taiyuan

30912

Georgia Cancer Center at Augusta University, Augusta

The Medical College of Georgia, Augusta

31008

Clinica Universitaria de Navarra (sede Navarra), Pamplona

31059

lnstitut Claudius Regaud - IUCT-O, Toulouse

31151

Soon Chun Hyang University Cheonan Hospital, Cheonan-si

Soon Chun Hyang University Hospital Cheonan, Cheonan-si

33075

lnstitut Bergonie Centre Regional de Lutte contre le Cancer, Bordeaux

33316

Broward Health Medical Center, Fort Lauderdale

36100

Oncologia di Vicenza - Ospedale San Bortolo, Vicenza

Unita Farmaci Antiblastici, Vicenza

39216

St. Dominic- Jackson Memorial Hospital Pharmacy Attn: Richard Wakefield, Jackson

40202

Norton Cancer Institute, Downtown, Louisville

Norton Hospital, Louisville

40207

Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD, Louisville

Norton Cancer Institute, St. Matthews Campus, Louisville

Norton Cancer Institute, Louisville

Norton Women's & Children's Hospital, Louisville

43026

Ohio State University Clinical Trials Management Office, Hilliard

OSU Wexner Medical Center, OSU Gynecologic Oncology at Mill Run, Hilliard

44106

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland

44111

Cleveland Clinic Fail·view Hospital, Cleveland

Cleveland Clinic Fairview Hospital- Moll Cancer Center lnvestigational Pharmacy, Cleveland

Cleveland Clinic Fairview Hospital, Cleveland

44124

Cleveland Clinic Hillcrest Hospital, Mayfield Heights

44195

Cleveland Clinic., Cleveland

Cleveland Clinic, Cleveland

44277

Hopital Prive du Confluent, Nantes-en-Ratier

HPC -Service d'Oncologie Medicale, Nantes

HPC -Service Pharmacie, Nantes

45127

KEM / Evang. Kliniken Essen-Mitte gGmbH, Essen

45136

KEM / Evang. Kliniken Essen-Mitte gGmbH, Essen

45147

University Hospital Essen, Clinic for Obstetrics and Gynecology, Essen

45239

KEM / Evang. Kliniken Essen-Mitte gGmbH Evang. Krankenhaus Essen Warden, Essen

46010

Hospital Universitario Clinico Valencia, INCLIVA, Valencia

51353

Samsung Changwon Hospital, Changwon-si

55102

Minnesota Oncology Hematology, P.A, Saint Paul

55109

Minnesota Oncology Hematology, P.A, Maplewood

55404

Minnesota Oncology Hematology, P.A, Minneapolis

55433

Minnesota Oncology Hematology PA, Coon Rapids

Minnesota Oncology Hematology, P.A, Coon Rapids

55435

Minnesota Oncology Hematology, P.A, Edina

60200

Onkologická ambulance Gynekologicko-porodnická klinika FN Brno, Brno

60611

Northwestern Medical Group, Chicago

Northwestern Memorial Hospital, Chicago

63108

Washington University in St Louis, St Louis

Washington University School of Medicine- Obstetrics & Gynecology [Academic Offices], St Louis

63110

Washington University School of Medicine [Patient Clinics], St Louis

Washington University School of Medicine-Obstetrics & Gynecology, St Louis

67033

Institut de Cancerologie de Strasbourg, Strasbourg

71103

Willis-Knighton Cancer Center Infusion Center, Shreveport

Willis-Knighton Physician Network/ Hematology-Oncology Associates, Shreveport

Willis-Knighton Physician Network/WK Gynecologic Oncology Associates, Shreveport

71118

Willis-Knighton Physician Network/WK Gynecologic Oncology Associates, Shreveport

75063

US Oncology lnvestigational Products Center (IPC), Irving

76104

Texas Oncology - Fort Worth Cancer Center, Fort Worth

80336

Augenklinik der LMU, München

81377

LMU Klinikum Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe, München

LMU Klinikum, München

85016

Arizona Oncology Associates P.C. - NAHOA, Phoenix

Arizona Oncology Associates, PC - HAL, Phoenix

85258

Arizona Oncology Associates, PC - HAL, Scottsdale

85284

Arizona Oncology Associates, PC - HAL, Tempe

85308

Arizona Oncology Associates, PC - HAL, Glendale

91342

Olive View - UCLA Medical Center, Sylmar

92697

University of California Irvine Health, Irvine

92868

UC Irvine Health (Investigator Site File Location), Orange

University of California Irvine Health, Orange

94805

lnstitut Gustave Roussy, Villejuif

100006

Beijing Obstetrics And Gynecology Hospital, Capital Medical University Bejing Maternal and Child, Beijng

100021

Cancer Hospital Chinese Academy of Medical Sciences (CAMS), Beijing

100044

Peking University People's Hospital, Beijing

110801

Liaoning Cancer Hospital, Shenyang

119074

National University Hospital, Singapore

130031

The First hospital of Jilin University, Changchun

168583

National Cancer Centre Singapore, Singapore

200080

Shanghai General Hospital, Shanghai

250117

Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital&Institute), Jinan

310022

Zhejiang Cancer Hospital, Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

333423

Chang Gung Memorial Hospital Linkou Branch, Taoyuan City Singapore

400030

Chongqing Cancer Hospital, Chongqing

410013

Hunan Cancer Hospital., Changsha

430023

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

530021

Affiliated Cancer Hospital of Guangxi Medical University, Nanning

610000

Sichuan Cancer hospital, Chengdu

710068

Shaanxi Provincial People's Hospital., Xi'an

06510

Yale University School of Medicine, New Haven

06520

Yale Cancer Center, New Haven

C1426ANZ

Instituto Médico Especializado Alexander Fleming, Buenos Aires

CP 2000

Sanatorio de la Mujer, Rosario

C1125 ABD

Fundacion CENIT para la lnvestigacion en Neurociencias, Buenos Aires

ZC 5000

IONC - Instituto Oncologico de Cordoba, Córdoba

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia, Ljui

90110-270

Hospital Mae de Deus, Porto Alegre

90610-000

Hospital de Sao Lucas da Pontificia Universidade CatoIica do Rio Grande do Sul -PUCRS, Porto Alegre

90850-170

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre

01321-001

A Beneficencia Portuguesa de Sao Paulo - BP Mirante, São Paulo

81520-060

Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner, Curitiba/PR

20220- 410

lnstituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA- Coordenacao de Pesquisa Clinica, Rio de Janeiro

01509-010

CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center - CAPEC Centro de Apoio a Pesquisa, São Paulo

04014-002

lnstituto Brasileiro de Controle do Cancer - IBCC, São Paulo

T6G 1Z2

Cross Cancer Institute Cancer Committee, Edmonton

V5Z 4E6

BC Cancer - Vancouver Center, Vancouver

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

S7N 0W8

Royal University Hospital, Saskatoon

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

Unknown

Sun Yat-Sen University Cancer Center, Guangzhou

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

Hubei Cancer Hospital., Wuhan

Union Hospital Affiliated to Tongji Medical College,Huazhong University of science and Technology, Wuhan

Xiangya Hospital of Central South University, Changsha

The Second People's Hospital of Yibin, Yibin

Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi

The Second Hospital of Dalian Medical University, Dalian

The Second Hospital of Hebei Medical University, Shijiazhuang

779 00

Onkologicka klinika FN Olomouc, Olomouc

75960 Cedex 20

Groupe Hospitalier Diaconesses Croix-Saint-Simon, Paris

00168

Policlinico Universitario Agostino Gemelli IRCCS, Rome

464-8681

Aichi Cancer Center Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

277-8567

The Jikei University Kashiwa Hospital, Kashiwa-shi

791-0280

NHO Shikoku Cancer Center, Matsuyama

791-0295

Ehime University Hospital, Tōon

830-0011

Kurume University Hospital, Kurume

373-8550

Gunma Prefectural Cancer Center, Ota-Shi

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

673-8558

Hyogo Cancer Center, Akashi

028-3695

Iwate Medical University Hospital, Shiwa-gun

211-8533

Nippon Medical School Musashikosugi Hospital, Kawasaki

901-2725

University of the Ryukyus Hospital, Ginowan

903-0215

University of the Ryukyus Hospital, Nakagami-gun

541-8567

Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka

350-1298

Saitama Medical University International Medical Center, Hidaka

411-8777

Shizuoka Cancer Center, Nagaizumi-cho

104-0045

National Cancer Center Hospital, Chuo-ku

105-8471

The Jikei University Hospital, Minato-ku

160-8582

Keio University Hospital, Shinjuku-ku

890-8520

Kagoshima University Hospital, Kagoshima

890-8760

Kagoshima City Hospital, Kagoshima

236-0004

Yokohama City University Hospital, Kanagawa

951-8566

Niigata Cancer Center Hospital, Niigata

700-8558

Okayama University Hospital, Okayama

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

C.P. 78209

Oncologico Potosino, San Luis Potosí City

3015GD

Erasmus Medisch Centrum Daniel Den Hoed, Rotterdam

11005 AZ

Amsterdam UMC, Department of Oncology, Amsterdam

6229 HX

MUMC+ Medical Oncology, Maastricht

6525 GA

Radboud UMC, afd Medische Oncologie (hp452), Nijmegen

3015 GD

Erasmus MC Interne Oncologie, Rotterdam

Erasmus University MC, Rotterdam

3584 CX

UMC Utrecht - Trialbureau Medische Oncologie, Utrecht

0379

Oslo Universitetssykehus HF, Radiumhospitalet, Oslo

0424

Sykehusapoteket Oslo, Radiumhospitalet, Oslo

15-027

Białostockie Centrum Onkologii, Bialystok

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

221 85

Kliniska forskningsenheten, VE Onkologi och Stralningsfysik, Lund

Skanes University Hospital, Lund

221 24

ApoEx AB, Kliniska provningar, Malmo

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genmab

INDUSTRY

lead

Seagen, a wholly owned subsidiary of Pfizer

INDUSTRY

NCT04697628 - Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer | Biotech Hunter | Biotech Hunter