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JOURNAL ONKOLOGIE – STUDIE
innovaTV 301

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Rekrutierend

NCT-Nummer:
NCT04697628

Studienbeginn:
Februar 2021

Letztes Update:
23.04.2024

Wirkstoff:
Tisotumab vedotin, Topotecan, Vinorelbine, Gemcitabine, Irinotecan, Pemetrexed

Indikation (Clinical Trials):
Uterine Cervical Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Seagen Inc.

Collaborator:
Genmab

Studienleiter

Medical Monitor
Study Director
Seagen Inc.

Kontakt

Studienlocations
(3 von 194)

Interdisziplinäres Brustkrebszentrum Kliniken Essen-Mitte
Henricistraße 92
45136 Essen
(Nordrhein-Westfalen)
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf (UKE)
20246 Hamburg
(Hamburg)
GermanyAktiv, nicht rekrutierend» Google-Maps
University Hospital LMU Munich
81377 Munchen
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
University of Alabama at Birmingham
35294-3300 Birmingham
United StatesAbgeschlossen» Google-Maps
Arizona Oncology Associates, PC - HAL
85016 Phoenix
United StatesAbgeschlossen» Google-Maps
Arizona Oncology Associates, PC - HOPE
85710 Tucson
United StatesAbgeschlossen» Google-Maps
University of California Irvine Medical Center
92697 Irvine
United StatesAktiv, nicht rekrutierend» Google-Maps
Olive View - UCLA Medical Center
91342 Sylmar
United StatesAktiv, nicht rekrutierend» Google-Maps
Yale Cancer Center
06520 New Haven
United StatesAktiv, nicht rekrutierend» Google-Maps
Broward Health Medical Center
33316 Fort Lauderdale
United StatesAktiv, nicht rekrutierend» Google-Maps
Augusta University
30912 Augusta
United StatesAktiv, nicht rekrutierend» Google-Maps
Northwestern Memorial Hospital
60611 Chicago
United StatesAbgeschlossen» Google-Maps
Gynecological Cancer Institute of Chicago, LLC
60453 Oak Lawn
United StatesAbgeschlossen» Google-Maps
Norton Cancer Institute
40207 Louisville
United StatesAktiv, nicht rekrutierend» Google-Maps
Willis-Knighton Physician Network/Gynecologic Oncology Associates
71103 Shreveport
United StatesAbgeschlossen» Google-Maps
Maryland Oncology Hematology, P.A.
21044 Columbia
United StatesAbgeschlossen» Google-Maps
Minnesota Oncology Hematology P.A.
55404 Minneapolis
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Dominic - Jackson Memorial Hospital
39216 Jackson
United StatesAktiv, nicht rekrutierend» Google-Maps
Washington University in St Louis
63108 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
Weill Cornell Medicine
11215 Brooklyn
United StatesAbgeschlossen» Google-Maps
Weill Cornell Medicine
11355 Flushing
United StatesAbgeschlossen» Google-Maps
New York University (NYU) Cancer Institute
10016 New York
United StatesAbgeschlossen» Google-Maps
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
27599 Chapel Hill
United StatesAbgeschlossen» Google-Maps
Cleveland Clinic Fairview Hospital
44111 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
Cleveland Clinic, The
44195 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
Ohio State University Clinical Trials Management Office
43026 Hilliard
United StatesAktiv, nicht rekrutierend» Google-Maps
Cleveland Clinic Hillcrest Hospital
44124 Mayfield Heights
United StatesAktiv, nicht rekrutierend» Google-Maps
Oncology Associates of Oregon
97401 Eugene
United StatesAbgeschlossen» Google-Maps
Northwest Cancer Specialists, P.C.
97227 Portland
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Austin Central
78731 Austin
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Fort Worth 12th Avenue
76104 Fort Worth
United StatesAktiv, nicht rekrutierend» Google-Maps
Texas Oncology - The Woodlands
77380 The Woodlands
United StatesAbgeschlossen» Google-Maps
University of Virginia
22901 Charlottesville
United StatesAktiv, nicht rekrutierend» Google-Maps
Virginia Oncology Associates
23502 Norfolk
United StatesAbgeschlossen» Google-Maps
Virginia Commonwealth University Medical Center
23219 Richmond
United StatesAktiv, nicht rekrutierend» Google-Maps
Carbone Cancer Center / University of Wisconsin
53792 Madison
United StatesAbgeschlossen» Google-Maps
Instituto Oncologico de Cordoba
X5006HBF Córdoba
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Instituto Alexander Fleming
1426 Caba
ArgentinaAktiv, nicht rekrutierend» Google-Maps
Sanatorio de la Mujer
2000 Rosario
ArgentinaAktiv, nicht rekrutierend» Google-Maps
AKH - Medizinische Universitat Wien
1090 Vienna
AustriaAktiv, nicht rekrutierend» Google-Maps
Institut Jules Bordet
B-1070 Anderlecht
BelgiumAktiv, nicht rekrutierend» Google-Maps
ZNA Middelheim
2020 Antwerpen
BelgiumAktiv, nicht rekrutierend» Google-Maps
Cliniques Universitaires Saint Luc
1200 Brussels
BelgiumAktiv, nicht rekrutierend» Google-Maps
Universitair Ziekenhuis Gent
9000 Gent
BelgiumAktiv, nicht rekrutierend» Google-Maps
UZ Leuven campus Gasthuisberg
3000 Leuven
BelgiumAktiv, nicht rekrutierend» Google-Maps
CHU UCL Namur-Site de Saint Elisabeth
5000 Namur
BelgiumAktiv, nicht rekrutierend» Google-Maps
Grand Hopital de Charleroi
6000 Charleroi
BelgiumAbgeschlossen» Google-Maps
Erasto Gaertner Hospital
81520-060 Curitiba
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital de Caridade de Ijui
98700-000 Ijui
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Mãe de Deus
90110-270 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Centro de Pesquisa em Oncologia - HSL-PUCRS
90610-000 Porto Alegre
BrazilAktiv, nicht rekrutierend» Google-Maps
Brazilian National Cancer Institute
20220---280 Rio de Janeiro
BrazilAktiv, nicht rekrutierend» Google-Maps
Hospital Beneficencia Portuguesa
01323-001 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Fundacao Antonio Prudente (AC Camargo Cancer Center)
01509-010 Sao Paulo
BrazilAktiv, nicht rekrutierend» Google-Maps
Instituto Brasileiro de Controle do Cancer
73801-340 Formosa
BrazilAktiv, nicht rekrutierend» Google-Maps
University of Alberta / Cross Cancer Institute
T6G 1Z2 Edmonton
CanadaAktiv, nicht rekrutierend» Google-Maps
British Columbia Cancer Agency - Vancouver Centre
V5Z 4E6 Vancouver
CanadaAktiv, nicht rekrutierend» Google-Maps
Sunnybrook Health Sciences Centre
M4N 3M5 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
University Health Network, Princess Margaret Hospital
M5G 2M9 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de l'Universite de Montreal
H2X 3E4 Montreal
CanadaAbgeschlossen» Google-Maps
Cancer Hospital Chinese Academy of Medical Sciences
100021 Beijing
ChinaRekrutierend» Google-Maps
Beijing Obstetrics and Gynecology Hospital
100026 Beijing
ChinaRekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaRekrutierend» Google-Maps
Jilin University - First Affiliated Hospital - Cancer Center
130000 Changchun
ChinaRekrutierend» Google-Maps
The Third Xiangya Hospital of Central South University
410008 Changsha
ChinaRekrutierend» Google-Maps
The Second Hospital of Dalian Medical University
Dalian
ChinaRekrutierend» Google-Maps
Sun Yat-sen University Cancer Center
510060 Guangzhou City
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Hangzhou City
ChinaRekrutierend» Google-Maps
Shanghai First People's Hospital
200060 Shanghai
ChinaRekrutierend» Google-Maps
Liaoning Cancer Hospital and Institute
110042 Shenyang
ChinaRekrutierend» Google-Maps
The Second Hospital of Hebei Medical University
050000 Shijiazhuang
ChinaRekrutierend» Google-Maps
The Second Hospital of Shanxi Medical University
030001 Taiyuan
ChinaRekrutierend» Google-Maps
Shanxi Province Cancer Hospital
30013 Taiyuan
ChinaRekrutierend» Google-Maps
The Affiliated Cancer Hospital of XinJiang Medical University
830054 Urumqi
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Wenzhou Medical University
325000 Wenzhou
ChinaRekrutierend» Google-Maps
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
430030 Wuhan City
ChinaRekrutierend» Google-Maps
Shaanxi Provincial People's Hospital
710068 Xi'an
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of Xinxiang Medical University
453700 Xinxiang
ChinaRekrutierend» Google-Maps
The Second People's Hospital of Yibin
644000 Yibin
ChinaRekrutierend» Google-Maps
Guangxi Medical University Affiliated Tumor Hospital
530021 Nanning
ChinaRekrutierend» Google-Maps
Fakultni nemocnice Brno
602 00 Brno-stred-Veveri
CzechiaAktiv, nicht rekrutierend» Google-Maps
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
779 00 Olomouc
CzechiaAktiv, nicht rekrutierend» Google-Maps
General University Hospital Prague
120 00 Praha 2
CzechiaAktiv, nicht rekrutierend» Google-Maps
Hospital Na Bulovce
18081 Praha 8-Liben
CzechiaAktiv, nicht rekrutierend» Google-Maps
University of Turku
20520 Turku
FinlandAktiv, nicht rekrutierend» Google-Maps
Tampere University Hospital
33520 Tampere
FinlandAbgeschlossen» Google-Maps
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
25000 Besancon Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
33076 Bordeaux
FranceAktiv, nicht rekrutierend» Google-Maps
Centre de Lutte contre le Cancer - Francois Baclesse
14076 Caen Cedex 5
FranceAbgeschlossen» Google-Maps
CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie
22190 Cotes d'Armor
FranceAktiv, nicht rekrutierend» Google-Maps
Institute Cancer De Lorraine (ICL) - Alexis Vautrin
54519 Moselle
FranceAbgeschlossen» Google-Maps
Hopital Prive du Confluent
44277 Nantes Cedex 2
FranceAktiv, nicht rekrutierend» Google-Maps
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon)
75020 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
Institut de cancerologie Strasbourg Europe
67200 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Claudius Regaud IUCT-O
31059 Toulouse Cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
National Institute of Oncology Hungary
1122 Budapest, Pest
HungaryAktiv, nicht rekrutierend» Google-Maps
Medical and Health Science Centre Debrecen Institution of Internal Medicine
4032 Debrecen, Hajdú-Bihar
HungaryAktiv, nicht rekrutierend» Google-Maps
Bacs-Kiskun Varmegyei Oktatokorhaz
H6000 Kecskemet
HungaryAktiv, nicht rekrutierend» Google-Maps
University Hospital Waterford
X91 ER8E Waterford
IrelandAbgeschlossen» Google-Maps
Azienda Ospedaliera per l'Emergenza
95126 Catania
ItalyAktiv, nicht rekrutierend» Google-Maps
Ospedale San Raffaele
20132 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino
00168 Roma
ItalyAktiv, nicht rekrutierend» Google-Maps
Hospital San Bortolo
36100 Vicenza
ItalyAktiv, nicht rekrutierend» Google-Maps
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
47014 Meldola
ItalyAbgeschlossen» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanAktiv, nicht rekrutierend» Google-Maps
Kurume University Hospital
830-0011 Fukuoka
JapanAbgeschlossen» Google-Maps
Gunma University Hospital
371-8511 Gunma
JapanAktiv, nicht rekrutierend» Google-Maps
Saitama Cancer Center
Hidaka-City
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
737-0023 Hiroshima
JapanAbgeschlossen» Google-Maps
Kagoshima University Hospital
890-8520 Kagoshima City
JapanAktiv, nicht rekrutierend» Google-Maps
Kagoshima City Hospital
890-8760 Kagoshima-City
JapanAktiv, nicht rekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanAktiv, nicht rekrutierend» Google-Maps
The Jikei University Kashiwa Hospital
277-8567 Kashiwashi
JapanAktiv, nicht rekrutierend» Google-Maps
Nippon Medical School Musashi Kosugi Hospital
211-8533 Kawasaki
JapanAktiv, nicht rekrutierend» Google-Maps
NHO Shikoku Cancer Center
791-0280 Matsuyama
JapanAbgeschlossen» Google-Maps
Aichi Cancer Center
464-8681 Nagoya-shi
JapanAktiv, nicht rekrutierend» Google-Maps
University of the Ryukyus Hospital
903-0215 Nakagami-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanAktiv, nicht rekrutierend» Google-Maps
Kindai University Hospital
589-8511 Osakasayama
JapanAbgeschlossen» Google-Maps
Osaka International Cancer Institute
541-8567 Osaka
JapanAktiv, nicht rekrutierend» Google-Maps
National Hospital Organization Hokkaido Cancer Center
003-0804 Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Hokkaido University Hospital
Sapporo-shi
JapanAktiv, nicht rekrutierend» Google-Maps
Iwate Medical University Hospital
Shiwa-gun
JapanAktiv, nicht rekrutierend» Google-Maps
Shizuoka Cancer Center
411-8777 Sunto-Gun
JapanAktiv, nicht rekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Keio University Hospital
160-8582 Tokyo
JapanAktiv, nicht rekrutierend» Google-Maps
Yokohama City University Hospital
232-0024 Yokohama
JapanAbgeschlossen» Google-Maps
Hyogo Cancer Center
673-8558 Akashi
JapanAktiv, nicht rekrutierend» Google-Maps
Ehime University Hospital
Ehime
JapanAktiv, nicht rekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8133 Niigata
JapanAbgeschlossen» Google-Maps
Keimyung University Dongsan Medical Center
42601 Daegu
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital
13605 Seongnam-si
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
CHA Bundang Medical Center
13496 Seongnam
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Korea Cancer Center Hospital
01802 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Soon Chun Hyang University Hospital Seoul
04401 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Seoul Saint Mary's Hospital
06591 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Ewha Womans University Mokdong Hospital
07985 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Severance Hospital, Yonsei University Health System
120-752 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Inje University Busan-Paik Hospital
47392 Busan
Korea, Republic ofAbgeschlossen» Google-Maps
Sungkyunkwan University of Medicine - Samsung Changwon Hospital
51353 Changwon, Kyungsangnam-do
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Gangnam Severance Hospital
06273 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Oncologico Potosino
78209 San Luis Potosi
MexicoAktiv, nicht rekrutierend» Google-Maps
Amsterdam UMC, Locatie AMC
1105 AZ Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Maastricht University Medical Center
6229 HX Maastricht
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Radboud University Medical Center
6525 GA Nijmegen
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Erasmus Medisch Centrum Daniel Den Hoed
3015GD Rotterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht
3584 CX Utrecht
NetherlandsAktiv, nicht rekrutierend» Google-Maps
Oslo University Hospital, Radiumhospitalet
0379 Olso
NorwayAktiv, nicht rekrutierend» Google-Maps
Trondheim University Hospital, Trondheim
7030 Trondheim
NorwayAbgeschlossen» Google-Maps
Hospital Maria Auxiliadora
15081 Lima
PeruAktiv, nicht rekrutierend» Google-Maps
Białostockie Centrum Onkologii
15-027 Białystok
PolandAktiv, nicht rekrutierend» Google-Maps
National University Cancer Institute, Singapore
119228 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
National Cancer Centre Singapore
169610 Singapore
SingaporeAktiv, nicht rekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Cordoba
SpainAktiv, nicht rekrutierend» Google-Maps
Clinica Universidad de Navarra
28027 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario La Paz
28046 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Linkoping University Hospital
581 85 Linköping
SwedenAbgeschlossen» Google-Maps
Skanes University Hospital - Universitetssjukhus
221 85 Lund
SwedenAbgeschlossen» Google-Maps
Uppsala University Hospital (Akademiska Sjukhuset)
75185 Uppsala
SwedenAbgeschlossen» Google-Maps
Mackay Memorial Hospital
10449 Taipei City
TaiwanAktiv, nicht rekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei City
TaiwanAbgeschlossen» Google-Maps
Chang Gung Memorial Hospital - Linkou
333 Taoyuan
TaiwanAktiv, nicht rekrutierend» Google-Maps
Cambridge University Hospitals NHS Foundation Trust
CB2 0QQ Cambridge
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Devon and Exeter NHS Foundation Trust
EX2 5DW Exeter
United KingdomAbgeschlossen» Google-Maps
The Royal Marsden Hospital
SW3 6JJ London
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Royal Marsden Hospital (Surrey)
SM2 5PT Sutton
United KingdomAktiv, nicht rekrutierend» Google-Maps
The Beatson West of Scotland Cancer Centre
G12 0YN Glasgow
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy

to treat cervical cancer. People in this study have cervical cancer that has spread to other

parts of the body (metastatic) or has come back after being treated (recurrent).

Participants in this trial will be randomly assigned to one of two groups. One group will be

treated with tisotumab vedotin. Participants in the other group will get one of five

different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or

irinotecan). Participants and their doctors will know which group they are in. Participants

in the chemotherapy group will decide with their study doctor which drug they will take.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (Time Frame - Up to approximately 2 years):
OS is defined as the time from the date of randomization to the date of death due to any cause.



Secondary outcome:

1. Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator (Time Frame - Up to approximately 1 year):
PFS per investigator is defined as the time from the date of randomization to the first documentation of disease progression per RECIST v.1.1 by the investigator, or to date of death due to any cause, whichever occurs earlier.

2. Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator (Time Frame - Up to approximately 6 months):
Confirmed objective response rate is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.

3. Time-to-response (TTR) as assessed by the investigator (Time Frame - Up to approximately 6 months):
TTR is defined as the time from the date of randomization to the date of first confirmed objective response (CR or PR that is subsequently confirmed). Only participants with confirmed CR or PR will be included in the analysis.

4. Duration of response (DOR) as assessed by the investigator (Time Frame - Up to approximately 1 year):
DOR is defined as the time from the date of first confirmed objective response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death from any cause, whichever occurs first. Only participants with confirmed CR or PR will be included in the analysis.

5. Incidence of adverse events (AEs) (Time Frame - Up to approximately 2 years):
Analyses of AEs will be summarized descriptively

6. Health-related quality of life as assessed by EQ-5D-5L index (Time Frame - Up to approximately 2 years):
EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

7. Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) (Time Frame - Up to approximately 2 years):
EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The EQ VAS records the participant's self-rated health on a vertical VAS. This can be used as a quantitative measure of health outcome that reflects the participant's own judgment.

8. Health-related quality of life as assessed by EORTC-QLQ-C30 (Time Frame - Up to approximately 6 months):
The QLQ-C30 is a validated questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess the quality of life of participants with cancer in multicultural clinical research settings.

9. Health-related quality of life as assessed by EORTC-QLQ-CX24 (Time Frame - Up to approximately 6 months):
The EORTC-QLQ-CX24 is a validated questionnaire developed by the EORTC to assess the quality of life in patients who are treated for cervical cancer both in clinical studies and in clinical practice.

Studien-Arme

  • Experimental: Tisotumab vedotin
    Tisotumab vedotin monotherapy
  • Active Comparator: Chemotherapy
    Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)

Geprüfte Regime

  • tisotumab vedotin (TIVDAK):
    2.0 mg/kg every 3 weeks (Q3W)
  • topotecan:
    1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
  • vinorelbine:
    30 mg/m2 IV on Days 1 and 8, every 21 days
  • gemcitabine:
    1000 mg/m2 IV on Days 1 and 8, every 21 days
  • irinotecan:
    100 or 125 mg/m2 IV weekly for 28 days, every 42 days
  • pemetrexed:
    500 mg/m2 IV on Day 1, every 21 days

Quelle: ClinicalTrials.gov


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"Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer"

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