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Cervical CancerPhase 1/2NCT03786081

Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer

A Phase 1/2 study testing Tisotumab Vedotin, Bevacizumab and Pembrolizumab in people with Cervical Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 71 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer. The trial consists of two-parts a dose escalation part and an expansion part. 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, Bevacizumab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
71 sitesin 10 countries
Study dates
27 Feb 2019to 19 Mar 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only).
  • 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).

Who cannot join

  • Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
  • 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)
Show all 9Show fewer
  • 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)

Trial locations and contacts

71 sites in 10 countries.

71 sites in 10 countries

United States25 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium

    Billings, Montana, 59102

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Chicago

    Chicago, Illinois, 60525

  • University of Cincinnati Physicians Group

    Cincinnati, Ohio, 45206

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • St Francis Hospital Cancer Center

    Greenville, South Carolina, 29607

  • Ohio State University Wexner Medical Center

    Hilliard, Ohio, 43026

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Oschner Clinic

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Univ California, Irvine Medical Center

    Orange, California, 92868

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Brown University - Women's and Infant Hospital

    Providence, Rhode Island, 02905

  • Carilion Clinic

    Roanoke, Virginia, 24016

  • Huntsman Cancer Center

    Salt Lake City, Utah, 84112

  • Olive View - UCLA Research and Education Institute

    Sylmar, California, 91342

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

Other trials in United States

Belgium12 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Universitaire Ziekenhuizen Leuven,

    Leuven

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800

  • Centre Hospitalier Universitaire (CHU) de Liège

    Liège, 4000

  • Grand Hôpital de Charleroi

    Loverval, 6280

  • CHU UCL Namur

    Namur, 5000

  • Sainte-Elisabeth

    Namur, 5000

Other trials in Belgium

Netherlands8 sites

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ

  • AMC Medical Research

    Amsterdam

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713 GZ

  • Radboudumc

    Nijmegen, 6525 GA

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CC

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015

  • UMC Utrecht

    Utrecht, 3508 GA

  • University Medical Center Utrecht (UMC Utrecht)

    Utrecht, 3584

Other trials in Netherlands

Czechia7 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Olomouc

    Olomouc, 77520

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 70852

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 51

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12851

  • Fakultni nemocnice Bulovka

    Prague, 180 81

  • Nemocnice Na Bulovce

    Prague, 18081

Other trials in Czechia

Italy5 sites

  • Azienda Ospedaliera Cannizzaro

    Catania, 95100

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

Other trials in Italy

Ireland4 sites

  • Cork University Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY

  • Waterford Regional Hospital

    Waterford, X91 ER8E

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital 12 De Octubre

    Madrid, 28041

Other trials in Spain

United Kingdom3 sites

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strathclyde, G12 OYN

  • Royal Marsden Hospital- Sutton

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Turkey (Türkiye)2 sites

  • Baskent University Adana Application and Research Center

    Adana, 01220

  • Baskent University Ankara Hospital

    Ankara, 06490

Other trials in Turkey (Türkiye)

Denmark1 site

  • Rigshospitalet

    Copenhagen, 5072

Other trials in Denmark

About this study

Official title: A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer

This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer.

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.

Read the detailed description

The dose escalation part will occur in participants with cervical cancer who have progressed during or after standard of care therapy and who are intolerant or ineligible to receive standard of care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin + carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin.

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
Cervical Cancer
Being tested
Tisotumab Vedotin, Bevacizumab, Pembrolizumab, Carboplatin
Keywords
cervical carcinoma
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

    Given into the vein (IV)

  • BevacizumabDrug

    Also called Avastin

    Given via IV

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Given via IV

  • CarboplatinDrug

    Also called Paraplatin

    Given via IV

Study groups in NCT03786081
Study groupRoleWhat they receive
A: Tisotumab Vedotin + bevacizumabExperimentalDose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
Receives: Drug: Tisotumab Vedotin; Drug: Bevacizumab
B: Tisotumab vedotin + pembrolizumabExperimentalDose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Receives: Drug: Tisotumab Vedotin; Drug: Pembrolizumab
C: Tisotumab vedotin + carboplatinExperimentalDose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
Receives: Drug: Tisotumab Vedotin; Drug: Carboplatin
D: Tisotumab vedotin + carboplatinExperimentalDose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
Receives: Drug: Tisotumab Vedotin; Drug: Carboplatin
E: Tisotumab vedotin + pembrolizumabExperimentalDose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
Receives: Drug: Tisotumab Vedotin; Drug: Pembrolizumab
F: Tisotumab vedotin + pembrolizumabExperimentalDose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Receives: Drug: Tisotumab Vedotin; Drug: Pembrolizumab
G: Tisotumab vedotin monotherapyExperimentalDose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.
Receives: Drug: Tisotumab Vedotin
H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumabExperimentalDose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients
Receives: Drug: Tisotumab Vedotin; Drug: Bevacizumab; Drug: Pembrolizumab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose escalation: Dose Limiting Toxicities (DLTs)

    To establish the MTD and RP2D of tisotumab vedotin in combination

    Measured: DLTs will be identified during the first treatment cycle (21 day cycles)

  2. Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Objective response is defined as confirmed partial response (PR) or complete response (CR)

    Measured: approximately 2 years

Secondary outcomes (12)

  1. Number of adverse events (AEs)

    Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.

    Measured: up to 2 years

  2. Dose escalation: ORR per RECIST v1.1

    Objective response is defined as confirmed PR or CR.

    Measured: approximately 2 years

  3. Duration of Response (DOR) per RECIST v1.1 by investigator assessment

    Will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (PD) or death.

    Measured: approximately 2 years

  4. Time to Response (TTR) per RECIST v1.1 by investigator assessment

    Will be calculated from the date of the first dose to the date of the initial documentation of response (CR or PR).

    Measured: approximately 2 years

  5. Progression free survival (PFS) per RECIST v1.1 by investigator assessment

    The time from the date of the first trial drug administration to the date of the first documented disease progression or death due to any cause.

    Measured: approximately 2 years

  6. Overall Survival (OS)

    The time from the date of the first trial drug administration to the date of death due to any cause.

    Measured: approximately 2 years

  7. Maximum concentration (Cmax) (All Arms except G)

    Pharmacokinetic (PK) parameter

    Measured: Up to 42 days

  8. Cmax (Arm G only)

    PK parameter

    Measured: Up to 2 years

  9. Trough Concentration (Ctrough) (All Arms)

    PK parameter

    Measured: Up to 2 years

  10. Area under the concentration-time curve (AUC) (All Arms except G)

    PK parameter

    Measured: Through 21 days after first dose

  11. AUC (Arm G only)

    PK parameter

    Measured: Through 8 days after first dose

  12. Anti-drug antibodies (ADAs)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2018
  2. Study start27 Feb 2019
  3. Primary completion19 Mar 2026
  4. Study completion19 Mar 2026

Why it stopped: Sponsor has decided to stop the trial based on strategic decisions

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03786081
Sponsor's protocol ID
GCT1015-05
Other IDs
InnovaTV 205, MK-3475-834, ENGOT-cx8, GOG-3024, KEYNOTE-834, 2017-004758-40, 2017
Status last verified
Jul 2026
First submitted
13 Dec 2018
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Van Nieuwenhuysen E, Vergote I, Randall LM, Tromp J, Lorusso D, O'Cearbhaill RE, Boere I, Pisano C, Sanchez LM, Banerjee S, Collins DC, Zikan M, Mathews C, Kummel J, Melichar B, Jackson AL, Madsen K, Gennigens C, Ottevanger N, Ghamande S, Salutari V, Baurain JF, Reyners AKL, Chisamore M, Conte U, Windfeld K, Geiger M, Hansen H, Denys H, Cibula D, Oaknin A, Van Gorp T, Monk BJ; innovaTV 205/ENGOT-cx8/GOG-3024 investigators. Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study. Gynecol Oncol. 2026 Apr;207S:3-13. doi: 10.1016/j.ygyno.2026.02.008.

    PubMed 42000372

  • 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.

    PubMed 37651655

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tisotumab Vedotin, Bevacizumab and Pembrolizumab in people with Cervical Cancer, run by Seagen, a wholly owned subsidiary of Pfizer at 71 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Belgium, Netherlands, Czechia, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor has decided to stop the trial based on strategic decisions). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation: Dose Limiting Toxicities (DLTs) (time frame: DLTs will be identified during the first treatment cycle (21 day cycles)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03786081, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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