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New hope for advanced cervical cancer: targeted drug combo shows promise

NCT ID NCT03786081

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This trial tested a drug called tisotumab vedotin, alone or with other medicines, in people with cervical cancer that had come back or spread. The study included 214 participants and aimed to find the best dose and see if the tumors shrank. The trial was stopped early, but the results help guide future treatments for advanced cervical cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

214 people

The number who actually took part.

Started

Feb 2019

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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) * 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)

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Conditions

The condition(s) this trial relates to.

cervical cancer Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

Contacts and locations

Locations

  • AMC Medical Research

    Amsterdam, Netherlands

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ, Netherlands

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Cannizzaro

    Catania, 95100, Italy

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207, United States

  • Baskent University Adana Application and Research Center

    Adana, 01220, Turkey (Türkiye)

  • Baskent University Ankara Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Beatson West of Scotland Cancer Centre

    Glasgow, Strathclyde, G12 OYN, United Kingdom

  • Billings Clinic Cancer Center

    Billings, Montana, 59101, United States

  • Brown University - Women's and Infant Hospital

    Providence, Rhode Island, 02905, United States

  • CHU UCL Namur

    Namur, 5000, Belgium

  • Carilion Clinic

    Roanoke, Virginia, 24016, United States

  • Centre Hospitalier Universitaire (CHU) de Liège

    Liège, 4000, Belgium

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800, Belgium

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Cork University Hospital

    Cork, Ireland

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CC, Netherlands

  • Erasmus University Medical Center Rotterdam

    Rotterdam, 3015, Netherlands

  • Fakultni nemocnice Bulovka

    Prague, 180 81, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 77520, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 70852, Czechia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168, Italy

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Grand Hôpital de Charleroi

    Charleroi, 6000, Belgium

  • Grand Hôpital de Charleroi

    Loverval, 6280, Belgium

  • Hospital 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, 30120, Spain

  • Huntsman Cancer Center

    Salt Lake City, Utah, 84112, United States

  • IEO Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY, Ireland

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montana Cancer Consortium

    Billings, Montana, 59102, United States

  • Nemocnice Na Bulovce

    Prague, 18081, Czechia

  • Ohio State University Wexner Medical Center

    Hilliard, Ohio, 43026, United States

  • Olive View - UCLA Research and Education Institute

    Sylmar, California, 91342, United States

  • Oschner Clinic

    New Orleans, Louisiana, 70121, United States

  • Radboudumc

    Nijmegen, 6525 GA, Netherlands

  • Rigshospitalet

    Copenhagen, 5072, Denmark

  • Royal Marsden Hospital- Sutton

    Sutton, Surrey, SM2 5PT, United Kingdom

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203, United States

  • Sainte-Elisabeth

    Namur, 5000, Belgium

  • St Francis Hospital Cancer Center

    Greenville, South Carolina, 29607, United States

  • UMC Utrecht

    Utrecht, 3508 GA, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • Univ California, Irvine Medical Center

    Orange, California, 92868, United States

  • Universitair Medisch Centrum Groningen (UMCG)

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Antwerpen (UZA)

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitaire Ziekenhuizen Leuven,

    Leuven, Belgium

  • University Hospital Waterford

    Waterford, Ireland

  • University Medical Center Utrecht (UMC Utrecht)

    Utrecht, 3584, Netherlands

  • University of Chicago

    Chicago, Illinois, 60525, United States

  • University of Cincinnati Physicians Group

    Cincinnati, Ohio, 45206, United States

  • University of Kansas Medical Center

    Westwood, Kansas, 66205, United States

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL, United Kingdom

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 51, Czechia

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12851, Czechia

  • Waterford Regional Hospital

    Waterford, X91 ER8E, Ireland

More trials for these conditions

Other studies related to the condition(s) this trial covers.