Cervical CancerPhase 3innovaTV 301NCT04697628
Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer
A Phase 3 study testing tisotumab vedotin, topotecan and vinorelbine in people with Cervical Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 211 sites in 25 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- tisotumab vedotin, topotecan and vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 211 sitesin 25 countries
- Study dates
- 22 Feb 2021to 15 Jan 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
211 sites in 25 countries.
211 sites in 25 countries
United States53 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
NewYork Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, 11215
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern Medical Group
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106
Cleveland Clinic Fail·view Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Fairview Hospital- Moll Cancer Center lnvestigational Pharmacy
Cleveland, Ohio, 44111
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic.
Cleveland, Ohio, 44195
Cleveland Clinic
Cleveland, Ohio, 44195
Minnesota Oncology Hematology PA
Coon Rapids, Minnesota, 55433
Minnesota Oncology Hematology, P.A
Coon Rapids, Minnesota, 55433
Minnesota Oncology Hematology, P.A
Edina, Minnesota, 55435
NewYork Presbyterian - Queens
Flushing, New York, 11355
NewYork Presbyterian - Queens
Forest Hills, New York, 11375
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, 76104
Arizona Oncology Associates, PC - HAL
Glendale, Arizona, 85308
OSU Wexner Medical Center, OSU Gynecologic Oncology at Mill Run
Hilliard, Ohio, 43026
University of California Irvine Health
Irvine, California, 92697
US Oncology lnvestigational Products Center (IPC)
Irving, Texas, 75063
St. Dominic- Jackson Memorial Hospital Pharmacy Attn: Richard Wakefield
Jackson, Mississippi, 39216
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
Norton Hospital
Louisville, Kentucky, 40202
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD
Louisville, Kentucky, 40207
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, 40207
Norton Cancer Institute
Louisville, Kentucky, 40207
Norton Women's & Children's Hospital
Louisville, Kentucky, 40207
Minnesota Oncology Hematology, P.A
Maplewood, Minnesota, 55109
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Minnesota Oncology Hematology, P.A
Minneapolis, Minnesota, 55404
Yale University School of Medicine
New Haven, Connecticut, 06520
Laura and Isaac Perlmutter Cancer Center at NYU Langone.
New York, New York, 10016
NYU Langone Medical Center
New York, New York, 10016
UC Irvine Health (Investigator Site File Location)
Orange, California, 92868
University of California Irvine Health
Orange, California, 92868
Arizona Oncology Associates P.C. - NAHOA
Phoenix, Arizona, 85016
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, 85016
Virginia Commonwealth University
Richmond, Virginia, 23219
VCU Health, Investigational Drug Service (ATTN: Henly Deutsch, RPh)
Richmond, Virginia, 23298
Minnesota Oncology Hematology, P.A
Saint Paul, Minnesota, 55102
Arizona Oncology Associates, PC - HAL
Scottsdale, Arizona, 85258
Willis-Knighton Cancer Center Infusion Center
Shreveport, Louisiana, 71103
Willis-Knighton Physician Network/ Hematology-Oncology Associates
Shreveport, Louisiana, 71103
Willis-Knighton Physician Network/WK Gynecologic Oncology Associates
Shreveport, Louisiana, 71103
Willis-Knighton Physician Network/WK Gynecologic Oncology Associates
Shreveport, Louisiana, 71118
Washington University School of Medicine- Obstetrics & Gynecology [Academic Offices]
St Louis, Missouri, 63108
Washington University School of Medicine [Patient Clinics]
St Louis, Missouri, 63110
Washington University School of Medicine-Obstetrics & Gynecology
St Louis, Missouri, 63110
Olive View - UCLA Medical Center
Sylmar, California, 91342
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, 85284
China27 sites
Cancer Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing, 100021
Peking University People's Hospital
Beijing, 100044
Beijing Obstetrics And Gynecology Hospital, Capital Medical University Bejing Maternal and Child
Beijng, 100006
The First hospital of Jilin University
Changchun, Jilin, 130031
Hunan Cancer Hospital.
Changsha, Hunan, 410013
Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Cancer hospital
Chengdu, Sichuan, 610000
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
The Second Hospital of Dalian Medical University
Dalian
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
Zhejiang Cancer Hospital
Hangzhou, 310022
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital&Institute)
Jinan, Shandong, 250117
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, 530021
Shanghai General Hospital
Shanghai, 200080
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
The Second Hospital of Hebei Medical University
Shijiazhuang
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 30001
The Shanxi Cancer Hospital
Taiyuan, Shanxi, 30013
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Hubei Cancer Hospital.
Wuhan, Hubei
Union Hospital Affiliated to Tongji Medical College,Huazhong University of science and Technology
Wuhan, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
Shaanxi Provincial People's Hospital.
Xi'an, Shaanxi, 710068
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
The Second People's Hospital of Yibin
Yibin, Sichuan
Japan26 sites
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
University of the Ryukyus Hospital
Ginowan, Okinawa, 901-2725
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Kagoshima University Hospital
Kagoshima, 890-8520
Kagoshima City Hospital
Kagoshima, 890-8760
Yokohama City University Hospital
Kanagawa, 236-0004
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
The Jikei University Kashiwa Hospital
Kashiwa-shi, Chiba, 277-8567
Nippon Medical School Musashikosugi Hospital
Kawasaki, Kanagawa, 211-8533
Kurume University Hospital
Kurume, Fukuoka, 830-0011
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
The Jikei University Hospital
Minato-ku, Tokyo, 105-8471
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
University of the Ryukyus Hospital
Nakagami-gun, Okinawa, 903-0215
Niigata Cancer Center Hospital
Niigata, 951-8566
Okayama University Hospital
Okayama, 700-8558
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Gunma Prefectural Cancer Center
Ota-Shi, Gunma, 373-8550
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Ehime University Hospital
Tōon, Ehime, 791-0295
South Korea11 sites
Samsung Changwon Hospital
Changwon-si, Gyeongsangnam-do, 51353
Soon Chun Hyang University Cheonan Hospital
Cheonan-si, Chungcheongnam-do, 31151
Soon Chun Hyang University Hospital Cheonan
Cheonan-si, Chungcheongnam-do, 31151
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
CHA Bundang Medical Cneter, CHA University
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Brazil9 sites
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba/PR, 81520-060
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ljui, Rio Grande do Sul, 98700-000
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90110-270
Hospital de Sao Lucas da Pontificia Universidade CatoIica do Rio Grande do Sul -PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, 90850-170
lnstituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA- Coordenacao de Pesquisa Clinica
Rio de Janeiro, 20220- 410
A Beneficencia Portuguesa de Sao Paulo - BP Mirante
São Paulo, São Paulo, 01321-001
CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center - CAPEC Centro de Apoio a Pesquisa
São Paulo, 01509-010
lnstituto Brasileiro de Controle do Cancer - IBCC
São Paulo, 04014-002
France9 sites
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, 25030
lnstitut Bergonie Centre Regional de Lutte contre le Cancer
Bordeaux, 33075
HPC -Service d'Oncologie Medicale
Nantes, 44277
HPC -Service Pharmacie
Nantes, 44277
Groupe Hospitalier Diaconesses Croix-Saint-Simon
Paris, 75960 Cedex 20
Hopital Prive des Cotes d'Armor - Centre CARIO
Plérin, 22190
Institut de Cancerologie de Strasbourg
Strasbourg, 67033
lnstitut Claudius Regaud - IUCT-O
Toulouse, 31059
lnstitut Gustave Roussy
Villejuif, 94805
Germany9 sites
KEM / Evang. Kliniken Essen-Mitte gGmbH
Essen, 45127
KEM / Evang. Kliniken Essen-Mitte gGmbH
Essen, 45136
University Hospital Essen, Clinic for Obstetrics and Gynecology
Essen, 45147
KEM / Evang. Kliniken Essen-Mitte gGmbH Evang. Krankenhaus Essen Warden
Essen, 45239
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, North Rhine-Westphalia, 20246
UKE, Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Augenklinik der LMU
München, 80336
LMU Klinikum Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe
München, 81377
LMU Klinikum
München, 81377
Spain9 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clinic Barcelona
Barcelona, 08036
Hospital Universitario Reina Sofia
Córdoba, 14004
Clinica Universitaria de Navarra (sede Madrid)
Madrid, 28027
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Clínica Universidad de Navarra - Pamplona
Pamplona, Navarra, Comunidad Foral de, 31008
Clinica Universitaria de Navarra (sede Navarra)
Pamplona, Navarre, 31008
Hospital Universitario Clinico Valencia, INCLIVA
Valencia, 46010
Belgium7 sites
Institut Jules Bordet
Anderlecht, 1070
ZNA Middelheim
Antwerp, 2020
Cliniques Universitaires Saint Luc
Brussels, Brabant, 1200
UZ Gent
Ghent, 9000
UZ Leuven-Campus Gasthuisberg
Leuven, 3000
CHU de Liege - Sart Tilman
Liège, 4000
CHU UCL Namur-Site St-Elisabeth
Namur, 5000
Netherlands7 sites
Amsterdam UMC, Department of Oncology
Amsterdam, 11005 AZ
MUMC+ Medical Oncology
Maastricht, 6229 HX
Radboud UMC, afd Medische Oncologie (hp452)
Nijmegen, 6525 GA
Erasmus Medisch Centrum Daniel Den Hoed
Rotterdam, South Holland, 3015GD
Erasmus MC Clinical Trial Center
Rotterdam, 3015 GD
Erasmus MC Interne Oncologie
Rotterdam, 3015 GD
UMC Utrecht - Trialbureau Medische Oncologie
Utrecht, 3584 CX
Canada6 sites
Cross Cancer Institute Cancer Committee
Edmonton, Alberta, T6G 1Z2
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
BC Cancer - Vancouver Center
Vancouver, British Columbia, V5Z 4E6
Hungary6 sites
National Institute of Oncology,Department of Gynecology
Budapest, Other, 1122
Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika
Debrecen, 4032
Debreceni Egyetem, Klinikai Kozpont, Orvosi Kepalkoto Klinika-Radiologia
Debrecen, 4032
Debreceni Egyetem, Klinikai Kozpont, Szemklinika
Debrecen, 4032
Scanomed Kft.
Debrecen, 4032
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Bács-Kiskun county, 6000
Argentina4 sites
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Buenos Aires F.D., C1426ANZ
Fundacion CENIT para la lnvestigacion en Neurociencias
Buenos Aires, C1125 ABD
IONC - Instituto Oncologico de Cordoba
Córdoba, ZC 5000
Sanatorio de la Mujer
Rosario, Santa Fe Province, CP 2000
Czechia4 sites
Onkologická ambulance Gynekologicko-porodnická klinika FN Brno
Brno, 60200
Onkologicka klinika FN Olomouc
Olomouc, 779 00
Gynekologicko-porodnicka klinika 1. lekarske fakulty a Vseobecne fakultni nemocnice
Prague, 12000
Fakultni nemocnice Bulovka, Gynekologicko-porodnicka klinika
Praha 8-Liben, 18081
Italy4 sites
Servizio di Farmacia
Milan, Milan, 20132
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Other, 00168
Oncologia di Vicenza - Ospedale San Bortolo
Vicenza, Veneto, 36100
Unita Farmaci Antiblastici
Vicenza, Veneto, 36100
Taiwan4 sites
Clinical Pharmacy, Mackay Memorial Hospital
Taipei, 10449
Mackay Memorial Hospital
Taipei, 10449
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Chang Gung Memorial Hospital Linkou Branch
Taoyuan City Singapore, 333423
United Kingdom4 sites
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
Cambridge, England, CB2 0QQ
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
The Christie NHS Foundation Trust
Manchester, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Sweden3 sites
Kliniska forskningsenheten, VE Onkologi och Stralningsfysik
Lund, 221 85
Skanes University Hospital
Lund, 221 85
ApoEx AB, Kliniska provningar
Malmö, 221 24
Norway2 sites
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, 0379
Sykehusapoteket Oslo, Radiumhospitalet
Oslo, 0424
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre Singapore
Singapore, 168583
Finland1 site
Turku University Hospital, Lighthouse Hospital, Gynecology Outpatient Clinic
Turku, 20520
Peru1 site
RCI 621 Hospital Maria Auxiliadora Unidad de investigacion en Oncologia
Lima, 15081
About this study
Official title: 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.
- Conditions
- Cervical Cancer
- Being tested
- tisotumab vedotin, topotecan, vinorelbine, gemcitabine, irinotecan
- Keywords
- Seattle Genetics
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tisotumab vedotinDrug
Also called TIVDAK, PF-08046057
2.0 mg/kg every 3 weeks (Q3W)
topotecanDrug
1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
vinorelbineDrug
30 mg/m2 IV on Days 1 and 8, every 21 days
gemcitabineDrug
1000 mg/m2 IV on Days 1 and 8, every 21 days
irinotecanDrug
100 or 125 mg/m2 IV weekly for 28 days, every 42 days
pemetrexedDrug
500 mg/m2 IV on Day 1, every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Tisotumab vedotin | Experimental | Tisotumab vedotin monotherapy Receives: Drug: tisotumab vedotin |
| Chemotherapy | Active comparator | Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) Receives: Drug: topotecan; Drug: vinorelbine; Drug: gemcitabine; Drug: irinotecan; Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum up to 25 months)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: From start of treatment until end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start22 Feb 2021
- Primary completion24 Jul 2023
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697628
- Sponsor's protocol ID
- SGNTV-003
- Other IDs
- C5721002, 2023-503813-31-01, 2023
- Acronym
- innovaTV 301
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2021
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Jordan SE, Gonzalez-Martin A, Morlock R, Hubig L, Yonemori K, Eberst L, Zikan M, Kim HS, Banerjee S, Damian F, Salutari V, Henry S, Raimondo M, Kolinsky M, Woelber L, Tromp J, Hietanen S, Nishio S, Lee JY, Manso L, Cruz F, Barraclough L, Oaknin A, Van Nieuwenhuysen E, Randall L, Lo SH, Mutebi A, Abrahami D, Leary A, Vergote I. Patient-reported outcomes with tisotumab vedotin versus chemotherapy in patients with recurrent or metastatic cervical cancer: post hoc analyses from the open-label, randomized, phase 3 ENGOT-cx12/GOG-3057/innovaTV 301 trial. Int J Gynecol Cancer. 2026 Aug 11:104947. doi: 10.1016/j.ijgc.2026.104947. Online ahead of print.
PubMed 42680635Yonemori K, Nishio S, Suzuki S, Hasegawa K, Yunokawa M, Yamaguchi S, Okamoto A, Nakamura K, Kamiura S, Fujiwara K, Katsumata N, Kobayashi H, Usami T, Mochizuki A, Takehara K, Whalley E, Noguchi H, Soumaoro I, Slomovitz B, Vergote I. Tisotumab vedotin in Japanese patients with recurrent or metastatic cervical cancer: results from the innovaTV 301/ENGOT-cx12/GOG-3057 trial. Int J Gynecol Cancer. 2026 Apr;36(4):104450. doi: 10.1016/j.ijgc.2025.104450. Epub 2025 Dec 31.
PubMed 41644383Vergote 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.
PubMed 38959480