Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer
NCT ID: NCT03786081
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
214 participants
INTERVENTIONAL
2019-02-27
2026-03-31
Brief Summary
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The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.
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Detailed Description
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The dose expansion part of this study (Arms D through H) will be conducted in 2 populations: participants with cervical cancer who have not received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H) and participants with cervical cancer who have progressed on or after at least 1 but no more than 2 prior systemic therapies (Arms F and G).
Participants enrolled to Arms D, E, F and H will receive the RP2D of tisotumab vedotin established in the dose escalation part. Participants enrolled to Arm G will receive tisotumab vedotin weekly (at a dose lower than subjects in all other Arms) for three weeks and 1 week off (28-day treatment cycle).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Tisotumab Vedotin + bevacizumab
Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
Tisotumab Vedotin
Given into the vein (IV)
Bevacizumab
Given via IV
B: Tisotumab vedotin + pembrolizumab
Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Tisotumab Vedotin
Given into the vein (IV)
Pembrolizumab
Given via IV
C: Tisotumab vedotin + carboplatin
Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
Tisotumab Vedotin
Given into the vein (IV)
Carboplatin
Given via IV
D: Tisotumab vedotin + carboplatin
Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
Tisotumab Vedotin
Given into the vein (IV)
Carboplatin
Given via IV
E: Tisotumab vedotin + pembrolizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
Tisotumab Vedotin
Given into the vein (IV)
Pembrolizumab
Given via IV
F: Tisotumab vedotin + pembrolizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Tisotumab Vedotin
Given into the vein (IV)
Pembrolizumab
Given via IV
G: Tisotumab vedotin monotherapy
Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.
Tisotumab Vedotin
Given into the vein (IV)
H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients
Tisotumab Vedotin
Given into the vein (IV)
Bevacizumab
Given via IV
Pembrolizumab
Given via IV
Carboplatin
Given via IV
Interventions
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Tisotumab Vedotin
Given into the vein (IV)
Bevacizumab
Given via IV
Pembrolizumab
Given via IV
Carboplatin
Given via IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only).
* Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only).
* Must have baseline measurable disease per RECIST v1.1.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
* Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
* Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration.
* Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).
Exclusion Criteria
* Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
* Has clinically significant bleeding issues or risks
* Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H)
* Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only)
* Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H only)
* Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
* Clinically significant cardiac disease
* Requires anti-coagulation therapy (Arms A and H only)
18 Years
FEMALE
No
Sponsors
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Genmab
INDUSTRY
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Belgian Gynaecological Oncology Group
OTHER
GOG Foundation
NETWORK
Merck Sharp & Dohme LLC
INDUSTRY
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Locations
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Arizona Oncology Associates
Phoenix, Arizona, United States
Univ California, Irvine Medical Center
Orange, California, United States
Olive View - UCLA Research and Education Institute
Sylmar, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Oschner Clinic
New Orleans, Louisiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Montana Cancer Consortium
Billings, Montana, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
University of Cincinnati Physicians Group
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Hilliard, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown University - Women's and Infant Hospital
Providence, Rhode Island, United States
St Francis Hospital Cancer Center
Greenville, South Carolina, United States
Huntsman Cancer Center
Salt Lake City, Utah, United States
Carilion Clinic
Roanoke, Virginia, United States
AZ Sint-Jan
Bruges, , Belgium
Cliniques universitaires Saint-Luc
Brussels, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Universitaire Ziekenhuizen Leuven,
Leuven, , Belgium
Centre Hospitalier de l'Ardenne
Libramont, , Belgium
Centre Hospitalier Universitaire (CHU) de Liège
Liège, , Belgium
Grand Hôpital de Charleroi
Loverval, , Belgium
CHU UCL Namur
Namur, , Belgium
Sainte-Elisabeth
Namur, , Belgium
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice Bulovka
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
Cork University Hospital
Cork, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
Waterford Regional Hospital
Waterford, , Ireland
University Hospital Waterford
Waterford, , Ireland
Azienda Ospedaliera Cannizzaro
Catania, , Italy
IEO Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, , Italy
Amsterdam UMC, Locatie AMC
Amsterdam, , Netherlands
AMC Medical Research
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
University Medical Center Utrecht (UMC Utrecht)
Utrecht, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital 12 De Octubre
Madrid, , Spain
Baskent University Adana Application and Research Center
Adana, , Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, , Turkey (Türkiye)
Velindre Cancer Centre
Cardiff, South Glamorgan, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, United Kingdom
Royal Marsden Hospital- Sutton
Sutton, Surrey, United Kingdom
Countries
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References
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Vergote I, Van Nieuwenhuysen E, O'Cearbhaill RE, Westermann A, Lorusso D, Ghamande S, Collins DC, Banerjee S, Mathews CA, Gennigens C, Cibula D, Tewari KS, Madsen K, Kose F, Jackson AL, Boere IA, Scambia G, Randall LM, Sadozye A, Baurain JF, Gort E, Zikan M, Denys HG, Ottevanger N, Forget F, Mondrup Andreassen C, Eaton L, Chisamore MJ, Viana Nicacio L, Soumaoro I, Monk BJ. Tisotumab Vedotin in Combination With Carboplatin, Pembrolizumab, or Bevacizumab in Recurrent or Metastatic Cervical Cancer: Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. J Clin Oncol. 2023 Dec 20;41(36):5536-5549. doi: 10.1200/JCO.23.00720. Epub 2023 Aug 31.
Other Identifiers
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InnovaTV 205
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-834
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-cx8
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-3024
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-834
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004758-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GCT1015-05
Identifier Type: -
Identifier Source: org_study_id
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