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Completed Phase 3 Interventional Results available

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

ClinicalTrials.gov ID: NCT04697628

Public ClinicalTrials.gov record NCT04697628. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04697628
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
502 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 21, 2021
Primary completion
Jul 23, 2023
Completion
Jan 14, 2026
Last update posted
Feb 23, 2026

2021 – 2026

United States locations

U.S. sites
53
U.S. states
15
U.S. cities
31
Facility City State ZIP Site status
Arizona Oncology Associates, PC - HAL Glendale Arizona 85308
Arizona Oncology Associates P.C. - NAHOA Phoenix Arizona 85016
Arizona Oncology Associates, PC - HAL Phoenix Arizona 85016
Arizona Oncology Associates, PC - HAL Scottsdale Arizona 85258
Arizona Oncology Associates, PC - HAL Tempe Arizona 85284
University of California Irvine Health Irvine California 92697
UC Irvine Health (Investigator Site File Location) Orange California 92868
University of California Irvine Health Orange California 92868
Olive View - UCLA Medical Center Sylmar California 91342
Yale University School of Medicine New Haven Connecticut 06520
Broward Health Medical Center Fort Lauderdale Florida 33316
Georgia Cancer Center at Augusta University Augusta Georgia 30912
Northwestern Medical Group Chicago Illinois 60611
Northwestern Memorial Hospital Chicago Illinois 60611
Norton Cancer Institute, Downtown Louisville Kentucky 40202
Norton Hospital Louisville Kentucky 40202
Norton Cancer Institute, St. Matthews Campus, Attn. Becky Champion, PharmD Louisville Kentucky 40207
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky 40207
Norton Cancer Institute Louisville Kentucky 40207
Norton Women's & Children's Hospital Louisville Kentucky 40207
Willis-Knighton Cancer Center Infusion Center Shreveport Louisiana 71103
Willis-Knighton Physician Network/ Hematology-Oncology Associates Shreveport Louisiana 71103
Willis-Knighton Physician Network/WK Gynecologic Oncology Associates Shreveport Louisiana 71103
Willis-Knighton Physician Network/WK Gynecologic Oncology Associates Shreveport Louisiana 71118
Minnesota Oncology Hematology PA Coon Rapids Minnesota 55433
Minnesota Oncology Hematology, P.A Coon Rapids Minnesota 55433
Minnesota Oncology Hematology, P.A Edina Minnesota 55435
Minnesota Oncology Hematology, P.A Maplewood Minnesota 55109
Minnesota Oncology Hematology, P.A Minneapolis Minnesota 55404
Minnesota Oncology Hematology, P.A Saint Paul Minnesota 55102
St. Dominic- Jackson Memorial Hospital Pharmacy Attn: Richard Wakefield Jackson Mississippi 39216
Washington University School of Medicine- Obstetrics & Gynecology [Academic Offices] St Louis Missouri 63108
Washington University School of Medicine [Patient Clinics] St Louis Missouri 63110
Washington University School of Medicine-Obstetrics & Gynecology St Louis Missouri 63110
NewYork Presbyterian - Brooklyn Methodist Hospital Brooklyn New York 11215
NewYork Presbyterian - Queens Flushing New York 11355
NewYork Presbyterian - Queens Forest Hills New York 11375
Laura and Isaac Perlmutter Cancer Center at NYU Langone. New York New York 10016
NYU Langone Medical Center New York New York 10016
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Cleveland Ohio 44106
Cleveland Clinic Fail·view Hospital Cleveland Ohio 44111
Cleveland Clinic Fairview Hospital- Moll Cancer Center lnvestigational Pharmacy Cleveland Ohio 44111
Cleveland Clinic Fairview Hospital Cleveland Ohio 44111
Cleveland Clinic. Cleveland Ohio 44195
Cleveland Clinic Cleveland Ohio 44195
OSU Wexner Medical Center, OSU Gynecologic Oncology at Mill Run Hilliard Ohio 43026
Cleveland Clinic Hillcrest Hospital Mayfield Heights Ohio 44124
Texas Oncology - Fort Worth Cancer Center Fort Worth Texas 76104
US Oncology lnvestigational Products Center (IPC) Irving Texas 75063
University of Virginia Comprehensive Cancer Center Charlottesville Virginia 22903
University of Virginia Health System Charlottesville Virginia 22908
Virginia Commonwealth University Richmond Virginia 23219
VCU Health, Investigational Drug Service (ATTN: Henly Deutsch, RPh) Richmond Virginia 23298

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 158 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04697628, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 23, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04697628 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →