Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified January 2026 by Seagen, a wholly owned subsidiary of Pfizer
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Information Provided by (Responsible Party)
Seagen, a wholly owned subsidiary of Pfizer
Clinicaltrials.gov Identifier
NCT04697628
Other Study ID Numbers:
SGNTV-003
First Submitted
January 3, 2021
First Posted
January 5, 2021
Results First Posted
July 15, 2024
Last Update Posted
February 23, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Cervical Cancer
Drug: tisotumab vedotinDrug: topotecan

Study Design

Study TypeInterventional
Actual Enrollment502 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
Study Start DateFebruary 21, 2021
Actual Primary Completion DateJuly 23, 2023
Actual Study Completion DateJanuary 14, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Tisotumab vedotin
Tisotumab vedotin monotherapy
Drug: tisotumab vedotin
2.0 mg/kg every 3 weeks (Q3W)
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

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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)
  9. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsSeagen, a wholly owned subsidiary of Pfizer
Locations
Arizona Oncology Associates, PC - HAL | Glendale Arizona, United States, 85308Arizona Oncology Associates P.C. - NAHOA | Phoenix Arizona, United States, 85016Arizona Oncology Associates, PC - HAL | Phoenix Arizona, United States, 85016Arizona Oncology Associates, PC - HAL | Scottsdale Arizona, United States, 85258Arizona Oncology Associates, PC - HAL | Tempe Arizona, United States, 85284University of California Irvine Health | Irvine California, United States, 92697UC Irvine Health (Investigator Site File Location) | Orange California, United States, 92868University of California Irvine Health | Orange California, United States, 92868Olive View - UCLA Medical Center | Sylmar California, United States, 91342Yale University School of Medicine | New Haven Connecticut, United States, 06520Broward Health Medical Center | Fort Lauderdale Florida, United States, 33316Georgia Cancer Center at Augusta University | Augusta Georgia, United States, 30912Northwestern Medical Group | Chicago Illinois, United States, 60611Northwestern Memorial Hospital | Chicago Illinois, United States, 60611Norton Cancer Institute, Downtown | Louisville Kentucky, United States, 40202Norton Hospital | Louisville Kentucky, United States, 40202Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD | Louisville Kentucky, United States, 40207Norton Cancer Institute, St. Matthews Campus | Louisville Kentucky, United States, 40207Norton Cancer Institute | Louisville Kentucky, United States, 40207Norton Women's & Children's Hospital | Louisville Kentucky, United States, 40207Willis-Knighton Cancer Center Infusion Center | Shreveport Louisiana, United States, 71103Willis-Knighton Physician Network/ Hematology-Oncology Associates | Shreveport Louisiana, United States, 71103Willis-Knighton Physician Network/WK Gynecologic Oncology Associates | Shreveport Louisiana, United States, 71103Willis-Knighton Physician Network/WK Gynecologic Oncology Associates | Shreveport Louisiana, United States, 71118Minnesota Oncology Hematology PA | Coon Rapids Minnesota, United States, 55433Minnesota Oncology Hematology, P.A | Coon Rapids Minnesota, United States, 55433Minnesota Oncology Hematology, P.A | Edina Minnesota, United States, 55435Minnesota Oncology Hematology, P.A | Maplewood Minnesota, United States, 55109Minnesota Oncology Hematology, P.A | Minneapolis Minnesota, United States, 55404Minnesota Oncology Hematology, P.A | Saint Paul Minnesota, United States, 55102St. Dominic- Jackson Memorial Hospital Pharmacy Attn: Richard Wakefield | Jackson Mississippi, United States, 39216Washington University School of Medicine- Obstetrics & Gynecology [Academic Offices] | St Louis Missouri, United States, 63108Washington University School of Medicine [Patient Clinics] | St Louis Missouri, United States, 63110Washington University School of Medicine-Obstetrics & Gynecology | St Louis Missouri, United States, 63110NewYork Presbyterian - Brooklyn Methodist Hospital | Brooklyn New York, United States, 11215NewYork Presbyterian - Queens | Flushing New York, United States, 11355NewYork Presbyterian - Queens | Forest Hills New York, United States, 11375Laura and Isaac Perlmutter Cancer Center at NYU Langone. | New York New York, United States, 10016NYU Langone Medical Center | New York New York, United States, 10016Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Cleveland Ohio, United States, 44106Cleveland Clinic Fail·view Hospital | Cleveland Ohio, United States, 44111Cleveland Clinic Fairview Hospital- Moll Cancer Center lnvestigational Pharmacy | Cleveland Ohio, United States, 44111Cleveland Clinic Fairview Hospital | Cleveland Ohio, United States, 44111Cleveland Clinic. | Cleveland Ohio, United States, 44195Cleveland Clinic | Cleveland Ohio, United States, 44195OSU Wexner Medical Center, OSU Gynecologic Oncology at Mill Run | Hilliard Ohio, United States, 43026Cleveland Clinic Hillcrest Hospital | Mayfield Heights Ohio, United States, 44124Texas Oncology - Fort Worth Cancer Center | Fort Worth Texas, United States, 76104US Oncology lnvestigational Products Center (IPC) | Irving Texas, United States, 75063University of Virginia Comprehensive Cancer Center | Charlottesville Virginia, United States, 22903University of Virginia Health System | Charlottesville Virginia, United States, 22908Virginia Commonwealth University | Richmond Virginia, United States, 23219VCU Health, Investigational Drug Service (ATTN: Henly Deutsch, RPh) | Richmond Virginia, United States, 23298Instituto Médico Especializado Alexander Fleming | Buenos Aires Buenos Aires F.D., Argentina, C1426ANZSanatorio de la Mujer | Rosario Santa Fe Province, Argentina, CP 2000Fundacion CENIT para la lnvestigacion en Neurociencias | Buenos Aires , Argentina, C1125 ABDIONC - Instituto Oncologico de Cordoba | Córdoba , Argentina, ZC 5000Radiologie - Diagnosezentrum Urania | Vienna , Austria, 1010Cliniques Universitaires Saint Luc | Brussels Brabant, Belgium, 1200Institut Jules Bordet | Anderlecht , Belgium, 1070ZNA Middelheim | Antwerp , Belgium, 2020UZ Gent | Ghent , Belgium, 9000UZ Leuven-Campus Gasthuisberg | Leuven , Belgium, 3000CHU de Liege - Sart Tilman | Liège , Belgium, 4000CHU UCL Namur-Site St-Elisabeth | Namur , Belgium, 5000ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Ljui Rio Grande do Sul, Brazil, 98700-000Hospital Mae de Deus | Porto Alegre Rio Grande do Sul, Brazil, 90110-270Hospital de Sao Lucas da Pontificia Universidade CatoIica do Rio Grande do Sul -PUCRS | Porto Alegre Rio Grande do Sul, Brazil, 90610-000Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa | Porto Alegre Rio Grande do Sul, Brazil, 90850-170A Beneficencia Portuguesa de Sao Paulo - BP Mirante | São Paulo São Paulo, Brazil, 01321-001Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner | Curitiba/PR , Brazil, 81520-060lnstituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA- Coordenacao de Pesquisa Clinica | Rio de Janeiro , Brazil, 20220- 410CIPE Centro Internacional de Pesquisa - AC Camargo Cancer Center - CAPEC Centro de Apoio a Pesquisa | São Paulo , Brazil, 01509-010lnstituto Brasileiro de Controle do Cancer - IBCC | São Paulo , Brazil, 04014-002Cross Cancer Institute Cancer Committee | Edmonton Alberta, Canada, T6G 1Z2BC Cancer - Vancouver Center | Vancouver British Columbia, Canada, V5Z 4E6Sunnybrook Research Institute | Toronto Ontario, Canada, M4N 3M5Princess Margaret Cancer Centre | Toronto Ontario, Canada, M5G 2M9Royal University Hospital | Saskatoon Saskatchewan, Canada, S7N 0W8Saskatoon Cancer Centre | Saskatoon Saskatchewan, Canada, S7N 4H4Chongqing Cancer Hospital | Chongqing Chongqing Municipality, China, 400030Sun Yat-Sen University Cancer Center | Guangzhou Guangdong, China, The First Affiliated Hospital of Xinxiang Medical University | Xinxiang Henan, China, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan Hubei, China, 430023Hubei Cancer Hospital. | Wuhan Hubei, China, Union Hospital Affiliated to Tongji Medical College,Huazhong University of science and Technology | Wuhan Hubei, China, Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan Hubei, China, Hunan Cancer Hospital. | Changsha Hunan, China, 410013Xiangya Hospital of Central South University | Changsha Hunan, China, The First hospital of Jilin University | Changchun Jilin, China, 130031Liaoning Cancer Hospital | Shenyang Liaoning, China, 110801Shaanxi Provincial People's Hospital. | Xi'an Shaanxi, China, 710068Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital&Institute) | Jinan Shandong, China, 250117Second Hospital of Shanxi Medical University | Taiyuan Shanxi, China, 30001The Shanxi Cancer Hospital | Taiyuan Shanxi, China, 30013Sichuan Cancer hospital | Chengdu Sichuan, China, 610000The Second People's Hospital of Yibin | Yibin Sichuan, China, Affiliated Cancer Hospital of Xinjiang Medical University | Ürümqi Xinjiang Uygur Autonomous Region, China, The First Affiliated Hospital of Wenzhou Medical University | Wenzhou Zhejiang, China, 325000Cancer Hospital Chinese Academy of Medical Sciences (CAMS) | Beijing , China, 100021Peking University People's Hospital | Beijing , China, 100044Beijing Obstetrics And Gynecology Hospital, Capital Medical University Bejing Maternal and Child | Beijng , China, 100006The Second Hospital of Dalian Medical University | Dalian , China, Zhejiang Cancer Hospital | Hangzhou , China, 310022Affiliated Cancer Hospital of Guangxi Medical University | Nanning , China, 530021Shanghai General Hospital | Shanghai , China, 200080The Second Hospital of Hebei Medical University | Shijiazhuang , China, Onkologická ambulance Gynekologicko-porodnická klinika FN Brno | Brno , Czechia, 60200Onkologicka klinika FN Olomouc | Olomouc , Czechia, 779 00Gynekologicko-porodnicka klinika 1. lekarske fakulty a Vseobecne fakultni nemocnice | Prague , Czechia, 12000Fakultni nemocnice Bulovka, Gynekologicko-porodnicka klinika | Praha 8-Liben , Czechia, 18081Turku University Hospital, Lighthouse Hospital, Gynecology Outpatient Clinic | Turku , Finland, 20520Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz | Besançon , France, 25030lnstitut Bergonie Centre Regional de Lutte contre le Cancer | Bordeaux , France, 33075HPC -Service d'Oncologie Medicale | Nantes , France, 44277HPC -Service Pharmacie | Nantes , France, 44277Groupe Hospitalier Diaconesses Croix-Saint-Simon | Paris , France, 75960 Cedex 20Hopital Prive des Cotes d'Armor - Centre CARIO | Plérin , France, 22190Institut de Cancerologie de Strasbourg | Strasbourg , France, 67033lnstitut Claudius Regaud - IUCT-O | Toulouse , France, 31059lnstitut Gustave Roussy | Villejuif , France, 94805Universitaetsklinikum Hamburg-Eppendorf (UKE) | Hamburg North Rhine-Westphalia, Germany, 20246KEM / Evang. Kliniken Essen-Mitte gGmbH | Essen , Germany, 45127KEM / Evang. Kliniken Essen-Mitte gGmbH | Essen , Germany, 45136University Hospital Essen, Clinic for Obstetrics and Gynecology | Essen , Germany, 45147KEM / Evang. Kliniken Essen-Mitte gGmbH Evang. Krankenhaus Essen Warden | Essen , Germany, 45239UKE, Universitatsklinikum Hamburg-Eppendorf | Hamburg , Germany, 20246Augenklinik der LMU | München , Germany, 80336LMU Klinikum Klinik und Poliklinik fur Frauenheilkunde und Geburtshilfe | München , Germany, 81377LMU Klinikum | München , Germany, 81377Bacs-Kiskun Varmegyei Oktatokorhaz | Kecskemét Bács-Kiskun county, Hungary, 6000National Institute of Oncology,Department of Gynecology | Budapest Other, Hungary, 1122Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika | Debrecen , Hungary, 4032Debreceni Egyetem, Klinikai Kozpont, Orvosi Kepalkoto Klinika-Radiologia | Debrecen , Hungary, 4032Debreceni Egyetem, Klinikai Kozpont, Szemklinika | Debrecen , Hungary, 4032Scanomed Kft. | Debrecen , Hungary, 4032Servizio di Farmacia | Milan Milan, Italy, 20132Policlinico Universitario Agostino Gemelli IRCCS | Rome Other, Italy, 00168Oncologia di Vicenza - Ospedale San Bortolo | Vicenza Veneto, Italy, 36100Unita Farmaci Antiblastici | Vicenza Veneto, Italy, 36100Aichi Cancer Center Hospital | Nagoya Aichi-ken, Japan, 464-8681National Cancer Center Hospital East | Kashiwa Chiba, Japan, 277-8577The Jikei University Kashiwa Hospital | Kashiwa-shi Chiba, Japan, 277-8567NHO Shikoku Cancer Center | Matsuyama Ehime, Japan, 791-0280Ehime University Hospital | Tōon Ehime, Japan, 791-0295Kurume University Hospital | Kurume Fukuoka, Japan, 830-0011Gunma Prefectural Cancer Center | Ota-Shi Gunma, Japan, 373-8550National Hospital Organization Hokkaido Cancer Center | Sapporo Hokkaido, Japan, 003-0804Hokkaido University Hospital | Sapporo Hokkaido, Japan, 060-8648Hyogo Cancer Center | Akashi Hyōgo, Japan, 673-8558Iwate Medical University Hospital | Shiwa-gun Iwate, Japan, 028-3695Nippon Medical School Musashikosugi Hospital | Kawasaki Kanagawa, Japan, 211-8533University of the Ryukyus Hospital | Ginowan Okinawa, Japan, 901-2725University of the Ryukyus Hospital | Nakagami-gun Okinawa, Japan, 903-0215Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Osaka Osaka, Japan, 541-8567Saitama Medical University International Medical Center | Hidaka Saitama, Japan, 350-1298Shizuoka Cancer Center | Nagaizumi-cho Shizuoka, Japan, 411-8777National Cancer Center Hospital | Chuo-ku Tokyo, Japan, 104-0045The Jikei University Hospital | Minato-ku Tokyo, Japan, 105-8471Keio University Hospital | Shinjuku-ku Tokyo, Japan, 160-8582Kagoshima University Hospital | Kagoshima , Japan, 890-8520Kagoshima City Hospital | Kagoshima , Japan, 890-8760Yokohama City University Hospital | Kanagawa , Japan, 236-0004Niigata Cancer Center Hospital | Niigata , Japan, 951-8566Okayama University Hospital | Okayama , Japan, 700-8558The Cancer Institute Hospital of JFCR | Tokyo , Japan, 135-8550Oncologico Potosino | San Luis Potosí City , Mexico, C.P. 78209Erasmus Medisch Centrum Daniel Den Hoed | Rotterdam South Holland, Netherlands, 3015GDAmsterdam UMC, Department of Oncology | Amsterdam , Netherlands, 11005 AZMUMC+ Medical Oncology | Maastricht , Netherlands, 6229 HXRadboud UMC, afd Medische Oncologie (hp452) | Nijmegen , Netherlands, 6525 GAErasmus MC Clinical Trial Center | Rotterdam , Netherlands, 3015 GDErasmus MC Interne Oncologie | Rotterdam , Netherlands, 3015 GDUMC Utrecht - Trialbureau Medische Oncologie | Utrecht , Netherlands, 3584 CXOslo Universitetssykehus HF, Radiumhospitalet | Oslo , Norway, 0379Sykehusapoteket Oslo, Radiumhospitalet | Oslo , Norway, 0424RCI 621 Hospital Maria Auxiliadora Unidad de investigacion en Oncologia | Lima , Peru, 15081Białostockie Centrum Onkologii | Bialystok , Poland, 15-027National University Hospital | Singapore , Singapore, 119074National Cancer Centre Singapore | Singapore , Singapore, 168583Soon Chun Hyang University Cheonan Hospital | Cheonan-si Chungcheongnam-do, South Korea, 31151Soon Chun Hyang University Hospital Cheonan | Cheonan-si Chungcheongnam-do, South Korea, 31151National Cancer Center | Goyang-si Gyeonggi-do, South Korea, 10408CHA Bundang Medical Cneter, CHA University | Seongnam-si Gyeonggi-do, South Korea, 13496Seoul National University Bundang Hospital | Seongnam-si Gyeonggi-do, South Korea, 13620Samsung Changwon Hospital | Changwon-si Gyeongsangnam-do, South Korea, 51353Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital, Yonsei University Health System | Seoul , South Korea, 03722Asan medical Center | Seoul , South Korea, 05505Gangnam Severance Hospital | Seoul , South Korea, 06273Samsung Medical Center | Seoul , South Korea, 06351Clínica Universidad de Navarra - Pamplona | Pamplona Navarra, Comunidad Foral de, Spain, 31008Clinica Universitaria de Navarra (sede Navarra) | Pamplona Navarre, Spain, 31008Hospital Universitario Vall d'Hebron | Barcelona , Spain, 08035Hospital Clinic Barcelona | Barcelona , Spain, 08036Hospital Universitario Reina Sofia | Córdoba , Spain, 14004Clinica Universitaria de Navarra (sede Madrid) | Madrid , Spain, 28027Hospital Universitario 12 de Octubre | Madrid , Spain, 28041Hospital Universitario La Paz | Madrid , Spain, 28046Hospital Universitario Clinico Valencia, INCLIVA | Valencia , Spain, 46010Kliniska forskningsenheten, VE Onkologi och Stralningsfysik | Lund , Sweden, 221 85Skanes University Hospital | Lund , Sweden, 221 85ApoEx AB, Kliniska provningar | Malmö , Sweden, 221 24Clinical Pharmacy, Mackay Memorial Hospital | Taipei , Taiwan, 10449Mackay Memorial Hospital | Taipei , Taiwan, 10449Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital | Taoyuan , Taiwan, 333Chang Gung Memorial Hospital Linkou Branch | Taoyuan City Singapore , Taiwan, 333423Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital | Cambridge England, United Kingdom, CB2 0QQThe Royal Marsden NHS Foundation Trust | London , United Kingdom, SW3 6JJThe Christie NHS Foundation Trust | Manchester , United Kingdom, M20 4BXThe Royal Marsden NHS Foundation Trust | Sutton , United Kingdom, SM2 5PT
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full Text)
Documents provided by Seagen, a wholly owned subsidiary of Pfizer: Study Protocol  January 21, 2024Documents provided by Seagen, a wholly owned subsidiary of Pfizer: Statistical Analysis Plan  April 22, 2024