Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301)

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: tisotumab vedotin; Drug: topotecan; Drug: vinorelbine; Drug: gemcitabine; Drug: irinotecan; Drug: pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1125 ABD
    • Fundacion CENIT para la lnvestigacion en Neurociencias
  • Córdoba, Argentina, ZC 5000
    • IONC - Instituto Oncologico de Cordoba
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
      • Instituto Medico Especializado Alexander Fleming
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, CP 2000
      • Sanatorio de la Mujer
• Austria
  • Vienna, Austria, 1010
    • Radiologie - Diagnosezentrum Urania
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Ghent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven-Campus Gasthuisberg
  • Liège, Belgium, 4000
    • CHU de Liege - Sart Tilman
  • Namur, Belgium, 5000
    • CHU UCL Namur-Site St-Elisabeth
  • Brabant
    • Brussels, Brabant, Belgium, 1200
      • Cliniques Universitaires Saint Luc
• Brazil
  • Curitiba/PR, Brazil, 81520-060
    • Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner
  • Rio de Janeiro, Brazil, 20220- 410
    • lnstituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA- Coordenacao de Pesquisa Clinica
  • São Paulo, Brazil, 01509-010
    • CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center - CAPEC Centro de Apoio a Pesquisa
  • São Paulo, Brazil, 04014-002
    • lnstituto Brasileiro de Controle do Cancer - IBCC
  • Rio Grande do Sul
    • Ljui, Rio Grande do Sul, Brazil, 98700-000
      • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
    • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
      • Hospital Mae de Deus
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital de Sao Lucas da Pontificia Universidade CatoIica do Rio Grande do Sul -PUCRS
    • Porto Alegre, Rio Grande do Sul, Brazil, 90850-170
      • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01321-001
      • A Beneficencia Portuguesa de Sao Paulo - BP Mirante
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute Cancer Committee
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer - Vancouver Center
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences (CAMS)
  • Beijng, China, 100006
    • Beijing Obstetrics And Gynecology Hospital, Capital Medical University Bejing Maternal and Child
  • Dalian, China
    • The Second Hospital of Dalian Medical University
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Nanning, China, 530021
    • Affiliated Cancer Hospital of Guangxi Medical University
  • Shanghai, China, 200080
    • Shanghai General Hospital
  • Shijiazhuang, China
    • The Second Hospital of Hebei Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun yat-sen University Cancer Center
  • Henan
    • Xinxiang, Henan, China
      • The First Affiliated Hospital of Xinxiang Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430023
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital.
    • Wuhan, Hubei, China
      • Union Hospital Affiliated to Tongji Medical College,Huazhong University of science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital.
  • Jilin
    • Changchun, Jilin, China, 130031
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Liaoning Cancer Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Shaanxi Provincial People's Hospital.
  • Shandong
    • Jinan, Shandong, China, 250117
      • Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital&Institute)
  • Shanxi
    • Taiyuan, Shanxi, China, 30001
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China, 30013
      • The Shanxi Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Sichuan Cancer Hospital
    • Yibin, Sichuan, China
      • The Second People's Hospital of Yibin
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Brno, Czechia, 60200
    • Onkologická ambulance Gynekologicko-porodnická klinika FN Brno
  • Olomouc, Czechia, 779 00
    • Onkologicka klinika FN Olomouc
  • Prague, Czechia, 12000
    • Gynekologicko-porodnicka klinika 1. lekarske fakulty a Vseobecne fakultni nemocnice
  • Praha 8-Liben, Czechia, 18081
    • Fakultni nemocnice Bulovka, Gynekologicko-porodnicka klinika
• Finland
  • Turku, Finland, 20520
    • Turku University Hospital, Lighthouse Hospital, Gynecology Outpatient Clinic
• France
  • Besançon, France, 25030
    • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
  • Bordeaux, France, 33075
    • lnstitut Bergonie Centre Regional de Lutte contre le Cancer
  • Nantes, France, 44277
    • HPC -Service d'Oncologie Medicale
  • Nantes, France, 44277
    • HPC -Service Pharmacie
  • Paris, France, 75960 Cedex 20
    • Groupe Hospitalier Diaconesses Croix-Saint-Simon
  • Plérin, France, 22190
    • Hopital Prive des Cotes d'Armor - Centre CARIO
  • Strasbourg, France, 67033
    • Institut de Cancerologie de Strasbourg
  • Toulouse, France, 31059
    • lnstitut Claudius Regaud - IUCT-O
  • Villejuif, France, 94805
    • lnstitut Gustave Roussy
• Germany
  • Essen, Germany, 45127
    • KEM / Evang. Kliniken Essen-Mitte gGmbH
  • Essen, Germany, 45136
    • KEM / Evang. Kliniken Essen-Mitte gGmbH
  • Essen, Germany, 45147
    • University Hospital Essen, Clinic for Obstetrics and Gynecology
  • Essen, Germany, 45239
    • KEM / Evang. Kliniken Essen-Mitte gGmbH Evang. Krankenhaus Essen Warden
  • Hamburg, Germany, 20246
    • UKE, Universitatsklinikum Hamburg-Eppendorf
  • München, Germany, 81377
    • LMU Klinikum
  • München, Germany, 80336
    • Augenklinik der LMU
  • München, Germany, 81377
    • LMU Klinikum Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe
  • North Rhine-Westphalia
    • Hamburg, North Rhine-Westphalia, Germany, 20246
      • Universitaetsklinikum Hamburg-Eppendorf (UKE)
• Hungary
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Orvosi Kepalkoto Klinika-Radiologia
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem, Klinikai Kozpont, Szemklinika
  • Debrecen, Hungary, 4032
    • Scanomed Kft.
  • Bács-Kiskun county
    • Kecskemét, Bács-Kiskun county, Hungary, 6000
      • Bacs-Kiskun Varmegyei Oktatokorhaz
  • Other
    • Budapest, Other, Hungary, 1122
      • National Institute of Oncology,Department of Gynecology
• Italy
  • Milan
    • Milan, Milan, Italy, 20132
      • Servizio di Farmacia
  • Other
    • Rome, Other, Italy, 00168
      • Policlinico Universitario Agostino Gemelli IRCCS
  • Veneto
    • Vicenza, Veneto, Italy, 36100
      • Oncologia di Vicenza - Ospedale San Bortolo
    • Vicenza, Veneto, Italy, 36100
      • Unita Farmaci Antiblastici
• Japan
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Kagoshima, Japan, 890-8760
    • Kagoshima City Hospital
  • Kanagawa, Japan, 236-0004
    • Yokohama City University Hospital
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital Of JFCR
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
    • Kashiwa-shi, Chiba, Japan, 277-8567
      • The Jikei University Kashiwa Hospital
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Nho Shikoku Cancer Center
    • Tōon, Ehime, Japan, 791-0295
      • Ehime University Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Gunma
    • Ota-Shi, Gunma, Japan, 373-8550
      • Gunma Prefectural Cancer Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyōgo
    • Akashi, Hyōgo, Japan, 673-8558
      • Hyogo Cancer Center
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashikosugi Hospital
  • Okinawa
    • Ginowan, Okinawa, Japan, 901-2725
      • University of the Ryukyus Hospital
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital
  • Osaka
    • Osaka, Osaka, Japan, 541-8567
      • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Shizuoka
    • Nagaizumi-cho, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • The Jikei University Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Mexico
  • San Luis Potosí City, Mexico, C.P. 78209
    • Oncologico Potosino
• Netherlands
  • Amsterdam, Netherlands, 11005 AZ
    • Amsterdam UMC, Department of Oncology
  • Maastricht, Netherlands, 6229 HX
    • MUMC+ Medical Oncology
  • Nijmegen, Netherlands, 6525 GA
    • Radboud UMC, afd Medische Oncologie (hp452)
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC Interne Oncologie
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC Clinical Trial Center
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht - Trialbureau Medische Oncologie
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015GD
      • Erasmus Medisch Centrum Daniel Den Hoed
• Norway
  • Oslo, Norway, 0379
    • Oslo Universitetssykehus HF, Radiumhospitalet
  • Oslo, Norway, 0424
    • Sykehusapoteket Oslo, Radiumhospitalet
• Peru
  • Lima, Peru, 15081
    • RCI 621 Hospital Maria Auxiliadora Unidad de investigacion en Oncologia
• Poland
  • Bialystok, Poland, 15-027
    • Białostockie Centrum Onkologii
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
• South Korea
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, South Korea, 31151
      • Soon Chun Hyang University Cheonan Hospital
    • Cheonan-si, Chungcheongnam-do, South Korea, 31151
      • Soon Chun Hyang University Hospital Cheonan
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10408
      • National Cancer Center
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • CHA Bundang Medical Cneter, CHA University
  • Gyeongsangnam-do
    • Changwon-si, Gyeongsangnam-do, South Korea, 51353
      • Samsung Changwon Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28027
    • Clinica Universitaria de Navarra (sede Madrid)
  • Valencia, Spain, 46010
    • Hospital Universitario Clinico Valencia, INCLIVA
  • Navarra, Comunidad Foral de
    • Pamplona, Navarra, Comunidad Foral de, Spain, 31008
      • Clinica Universidad de Navarra - Pamplona
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universitaria de Navarra (sede Navarra)
• Sweden
  • Lund, Sweden, 221 85
    • Skånes University Hospital
  • Lund, Sweden, 221 85
    • Kliniska forskningsenheten, VE Onkologi och Stralningsfysik
  • Malmo, Sweden, 221 24
    • ApoEx AB, Kliniska provningar
• Taiwan
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 10449
    • Clinical Pharmacy, Mackay Memorial Hospital
  • Taoyuan City Singapore, Taiwan, 333423
    • Chang Gung Memorial Hospital Linkou Branch
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust
  • England
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates P.C. - NAHOA
    • Scottsdale, Arizona, United States, 85258
      • Arizona Oncology Associates, PC - HAL
    • Tempe, Arizona, United States, 85284
      • Arizona Oncology Associates, PC - HAL
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine Health
    • Orange, California, United States, 92868
      • University of California Irvine Health
    • Orange, California, United States, 92868
      • UC Irvine Health (Investigator Site File Location)
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Broward Health Medical Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Cancer Center at Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St. Matthews Campus
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute, Downtown
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
    • Louisville, Kentucky, United States, 40207
      • Norton Women's & Children's Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Cancer Center Infusion Center
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Physician Network/ Hematology-Oncology Associates
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Physician Network/WK Gynecologic Oncology Associates
    • Shreveport, Louisiana, United States, 71118
      • Willis-Knighton Physician Network/WK Gynecologic Oncology Associates
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology PA
    • Coon Rapids, Minnesota, United States, 55433
      • Minnesota Oncology Hematology, P.A
    • Edina, Minnesota, United States, 55435
      • Minnesota Oncology Hematology, P.A
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology, P.A
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology, P.A
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Oncology Hematology, P.A
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St. Dominic- Jackson Memorial Hospital Pharmacy Attn: Richard Wakefield
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine- Obstetrics & Gynecology [Academic Offices]
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine [Patient Clinics]
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine-Obstetrics & Gynecology
  • New York
    • Brooklyn, New York, United States, 11215
      • NewYork Presbyterian - Brooklyn Methodist Hospital
    • Flushing, New York, United States, 11355
      • NewYork Presbyterian - Queens
    • Forest Hills, New York, United States, 11375
      • NewYork Presbyterian - Queens
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10016
      • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic.
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fail·view Hospital
    • Cleveland, Ohio, United States, 44111
      • Cleveland Clinic Fairview Hospital- Moll Cancer Center lnvestigational Pharmacy
    • Hilliard, Ohio, United States, 43026
      • OSU Wexner Medical Center, OSU Gynecologic Oncology at Mill Run
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic Hillcrest Hospital
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Irving, Texas, United States, 75063
      • US Oncology lnvestigational Products Center (IPC)
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Comprehensive Cancer Center
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23298
      • VCU Health, Investigational Drug Service (ATTN: Henly Deutsch, RPh)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tisotumab vedotin; Tisotumab vedotin monotherapy	Drug: tisotumab vedotin; 2.0 mg/kg every 3 weeks (Q3W); Other Names: TIVDAK; PF-08046057
Active Comparator: Chemotherapy; Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.	From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) as Assessed by Investigator	PFS per investigator was defined as the time from the date of randomization to the first documentation of disease progression (PD) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, or death due to any cause, whichever occurred earlier. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Participants without evidence of radiographic disease progression or death were censored at the date of last adequate tumor assessment prior to data cut-off date or start of new anti-cancer therapy. Participants with disease progression or death that occurred after 2 or more missed scans were censored at the last adequate tumor assessment prior to missed scans. Participants without post-baseline scan data were censored at the day of randomization.	From the date of randomization to first documentation of PD or death due to any cause, or censoring date whichever occurred first (maximum up to 25 months)
Confirmed Objective Response Rate (ORR) as Assessed by Investigator	Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The minimum criteria for stable disease (SD) duration are defined as ≥ 5 weeks after the date of randomization. For a response to be considered as confirmed, the subsequent response had to be at least 4 weeks after the initial response. Two-sided 95% exact confidence interval (CI) was computed using the Clopper-Pearson method.	From the date of randomization until date of confirmed CR or PR (maximum up to 25 months)
Time-to-Response (TTR) as Assessed by the Investigator	TTR was defined as the time from the randomization date to the date of the first confirmed objective response (CR or PR that was subsequently confirmed). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From the date of randomization to date of date of the first confirmed objective response (maximum up to 25 months)
Duration of Response (DOR) by Investigator Assessment	DOR was defined as the time from the date of the first confirmed objective response (CR or PR that was subsequently confirmed) to the date of the first documented PD per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.	From the date of first documented response of CR or PR to the first documented PD or death from any cause, whichever occurred first (maximum up to 25 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE was any untoward medical occurrence in a clinical study participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment and with onset date on or before 30 days after the last dose of study treatment.	From start of treatment up to 30 days after last dose of study treatment (up to 25 months)
EuroQOL Five Dimensions Five Level (EQ-5D-5L) Index Score	The EQ-5D-5L questionnaire is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems). Responses to the 5 items are then converted to a weighted health state index (utility score) based on values derived from general population samples. This health utility score is between 0 and 1, where 0 is death and 1 is perfect health.	From start of treatment until end of follow-up
EQ-5D Visual Analog Scale (VAS) Scores	EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state) ; higher scores indicate a better health state.	From start of treatment until end of follow-up
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Total Score	The EORTC-QLQ-C30 questionnaire is composed of 30 questions for which the answers ranges either from 1 (not at all) to 4 (very much) for items 1 to 28, or from 1 (very poor) to 7 (excellent) for items 29 to 30. The EORTC QLQ-C30 scale scores will be calculated using the EORTC QLQ-C30 Scoring Manual. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items (i.e., no item occurs in more than one scale). All of the scales and single-item measures range in score from 0 to 100, with a high scale score representing a higher response level (e.g., a high level of functioning, a high QoL, or a high level of symptomatology/problems)	From start of treatment until end of follow-up
EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores	The EORTC QLQ-CX24 questionnaire is meant for use among cervical cancer participants varying in disease stage and treatment modality. The EORTC-QLQ-CX24 questionnaire is composed of 24 questions for which the answers ranged from 1 (Not at all) to 4 (Very much). Four functional scales and 5 symptom scales will be calculated using the EORTC QLQ-CX24 Scoring Manual. The 9 scores computed from the EORTC-QLQ-CX24 questionnaire will be summarized by treatment arm using descriptive statistics.	From start of treatment until end of follow-up

Collaborators and Investigators

• Sponsor: Seagen, a wholly owned subsidiary of Pfizer
• Collaborators: Genmab
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Vergote I, Gonzalez-Martin A, Fujiwara K, Kalbacher E, Bagameri A, Ghamande S, Lee JY, Banerjee S, Maluf FC, Lorusso D, Yonemori K, Van Nieuwenhuysen E, Manso L, Woelber L, Westermann A, Covens A, Hasegawa K, Kim BG, Raimondo M, Bjurberg M, Cruz FM, Angelergues A, Cibula D, Barraclough L, Oaknin A, Gennigens C, Nicacio L, Teng MSL, Whalley E, Soumaoro I, Slomovitz BM; innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024 Jul 4;391(1):44-55. doi: 10.1056/NEJMoa2313811.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Seattle Genetics
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Indoles; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Irinotecan; Vinorelbine; Pemetrexed; Gemcitabine; Topotecan; tisotumab vedotin
• Other Study ID Numbers: SGNTV-003; C5721002 (Other Identifier: Alias Study Number); 2023-503813-31-01 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No