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Cervical CancerPhase 4NCT06952660

Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer

A Phase 4 study testing TIVDAK in people with Cervical Cancer, run by Pfizer at 135 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. 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?
TIVDAK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
135 sitesin 2 countries
Study dates
7 May 2025to 13 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
  • Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
  • Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site
  • Must agree to use effective contraception according to the US Prescribing Information

Who cannot join

  • Active ocular disease at baseline per investigator assessment
  • Previous treatment with Tivdak
  • Previous administration of an investigational drug within 30 days
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'

Trial locations and contacts

135 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

135 sites in 2 countries

United States134 sites, 134 recruiting

  • Texas Oncology - DFW

    Arlington, Texas, 76012

    Recruiting

  • Grady Health System Correll Pavilion

    Atlanta, Georgia, 30303

    Recruiting

  • Grady Memorial Hospital Investigational Drug Service

    Atlanta, Georgia, 30303

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • The Emory Clinic

    Atlanta, Georgia, 30322

    Recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78731

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78745

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78758

    Recruiting

  • Mount Sinai Comprehensive Cancer Center - Aventura

    Aventura, Florida, 33180

    Recruiting

  • Intermountain Health Saint Vincent Regional Hospital

    Billings, Montana, 59101

    Recruiting

  • Saint Vincent Regional Hospital- Cancer Centers of Montana

    Billings, Montana, 59102

    Recruiting

  • Yellowstone Eye Care

    Billings, Montana, 59102

    Recruiting

  • Intermountain Health West End Clinic- Gynecologic Oncology

    Billings, Montana, 59106

    Recruiting

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

    Recruiting

  • Florida Cancer Specialists

    Bradenton, Florida, 34211

    Recruiting

  • Maimonides Medical Center

    Brooklyn, New York, 11220

    Recruiting

  • M Health Fairview Clinics and Specialty Center

    Burnsville, Minnesota, 55337

    Recruiting

  • MD Anderson Cancer Center at Cooper

    Camden, New Jersey, 08103

    Recruiting

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909

    Recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Recruiting

  • SCC at UH Geauga Medical Center

    Chardon, Ohio, 44024

    Recruiting

  • UVA Comprehensive Cancer Center

    Charlottesville, Virginia, 22903

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Recruiting

  • UVA Health Cancer Care Pantops

    Charlottesville, Virginia, 22911

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60607

    Recruiting

  • Rush University Medical Center, Ophthalmology

    Chicago, Illinois, 60612

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic Fairview Hospital

    Cleveland, Ohio, 44111

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Ohio Health Arthur G.H. Bing - MD Cancer Center

    Columbus, Ohio, 43214

    Not yet recruiting

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

    Not yet recruiting

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

    Not yet recruiting

  • Broward Health Coral Springs

    Coral Springs, Florida, 33065

    Recruiting

  • Parkland Health & Hospital System

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    Dallas, Texas, 75235

    Recruiting

  • University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital

    Dallas, Texas, 75390

    Recruiting

  • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75390

    Recruiting

  • University Of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117

    Recruiting

  • Broward Health North

    Deerfield Beach, Florida, 33064

    Recruiting

  • AdventHealth Hematology and Oncology Denver

    Denver, Colorado, 80210

    Recruiting

  • AdventHealth Medical Group Gynecologic Oncology at Porter

    Denver, Colorado, 80210

    Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010

    Recruiting

  • M Health Fairview Clinics and Surgery Center

    Edina, Minnesota, 55435

    Recruiting

  • UPMC Hillman Cancer Center-Erie

    Erie, Pennsylvania, 16505

    Recruiting

  • Florida Cancer Specialists

    Fleming Island, Florida, 32003

    Recruiting

  • Broward Health Imperial Point

    Fort Lauderdale, Florida, 33308

    Recruiting

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

    Recruiting

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

    Recruiting

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center - Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • Texas Oncology - Central South

    Harlingen, Texas, 78550

    Recruiting

  • Texas Oncology - Gulf Coast

    Houston, Texas, 77054

    Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • St. Dominic - Jackson Memorial Hospital

    Jackson, Mississippi, 39216

    Recruiting

  • St. Dominic Gynecologic Oncology

    Jackson, Mississippi, 39216

    Recruiting

  • Kettering Health Cancer Center

    Kettering, Ohio, 45429

    Recruiting

  • Kettering Health Main Campus

    Kettering, Ohio, 45429

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Recruiting

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, 40202

    Recruiting

  • Norton Hospital

    Louisville, Kentucky, 40202

    Recruiting

  • Norton Cancer Institute St Matthews Campus

    Louisville, Kentucky, 40207

    Recruiting

  • Norton Women's and Children's Hospital

    Louisville, Kentucky, 40207

    Recruiting

  • M Health Fairview Clinics and Surgery Center

    Maple Grove, Minnesota, 55369

    Recruiting

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109

    Recruiting

  • Cleveland Clinic Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

    Recruiting

  • Texas Oncology - Central South

    McAllen, Texas, 78503

    Recruiting

  • PinnacleHealth Women´s Cancer Center (Ortenzio Cancer Center)

    Mechanicsburg, Pennsylvania, 17050

    Recruiting

  • SCC at Lake University (LUSCC)

    Mentor, Ohio, 44060

    Recruiting

  • HCA Mercy Hospital

    Miami, Florida, 33133

    Recruiting

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

    Recruiting

  • Mount Sinai Medical Center of Florida, Inc

    Miami Beach, Florida, 33140

    Recruiting

  • M Health Fairview Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • UPMC Vision Institute

    Monroeville, Pennsylvania, 15146

    Recruiting

  • Florida Cancer Specialists

    N. Venice, Florida, 34275

    Recruiting

  • Florida Cancer Specialists

    Naples, Florida, 34102

    Recruiting

  • University Medical Center - New Orleans

    New Orleans, Louisiana, 70112

    Recruiting

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

    Not yet recruiting

  • IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy

    New York, New York, 10032

    Not yet recruiting

  • UH Minoff Health Center/Chagrin Highlands- Seidman Cancer Center

    Orange, Ohio, 44122

    Recruiting

  • AdventHealth

    Orlando, Florida, 32803

    Recruiting

  • AdventHealth Gynecologic Oncology

    Orlando, Florida, 32804

    Recruiting

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804

    Recruiting

  • AdventHealth

    Orlando, Florida, 32804

    Recruiting

  • Orlando Health Ambulatory Care Center

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Orlando Regional Medical Center

    Orlando, Florida, 32806

    Recruiting

  • Orlando Health Winnie Palmer Hospital for Women & Babies

    Orlando, Florida, 32806

    Recruiting

  • Florida Cancer Specialists

    Palm Beach Gardens, Florida, 33410

    Recruiting

  • Parma - Seidman Cancer Center

    Parma, Ohio, 44129

    Recruiting

  • Illinois Eye Center

    Peoria, Illinois, 61615

    Recruiting

  • OSF Saint Francis Medical Center (OSF SFMC)

    Peoria, Illinois, 61637

    Recruiting

  • HonorHealth Cancer Care - Biltmore - AZCCC Imaging

    Phoenix, Arizona, 85016

    Recruiting

  • HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy

    Phoenix, Arizona, 85016

    Recruiting

  • HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore

    Phoenix, Arizona, 85016

    Recruiting

  • Sonora Quest Laboratories, LLC

    Phoenix, Arizona, 85034

    Recruiting

  • South West Medical Imaging (SMIL)

    Phoenix, Arizona, 85258

    Recruiting

  • University Ear, Nose, & Throat Eye & Ear Institute

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Vision Institute - Mercy

    Pittsburgh, Pennsylvania, 15219

    Recruiting

  • University Ear, Nose, & Throat Specialists

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • UPMC Vision Institute Shadyside

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

    Recruiting

  • OHSU

    Portland, Oregon, 97239

    Recruiting

  • Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic

    Providence, Rhode Island, 02905

    Recruiting

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

    Recruiting

  • Women & Infant´s Hospital Infusion Center

    Providence, Rhode Island, 02905

    Recruiting

  • University of Texas Southwestern Simmons Cancer Center-Richardson/Plano

    Richardson, Texas, 75080

    Recruiting

  • Carilion Clinic Gynecologic Oncology

    Roanoke, Virginia, 24016

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

    Recruiting

  • Schwartz Laser Eye Center

    Scottsdale, Arizona, 85260

    Recruiting

  • Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy

    Scottsdale, Arizona, 85260

    Recruiting

  • Florida Cancer Specialists

    Sebring, Florida, 33870

    Recruiting

  • Trials365, LLC

    Shreveport, Louisiana, 71103

    Recruiting

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

    Recruiting

  • Willis Knighton Physician Network - Hematology/Oncology

    Shreveport, Louisiana, 71103

    Recruiting

  • Willis Knighton Physician Network/Gynecologic Oncology Associates

    Shreveport, Louisiana, 71103

    Recruiting

  • WK Eye Institute North

    Shreveport, Louisiana, 71103

    Recruiting

  • Willis Knighton Physician Network/Gynecologic Oncology Associates

    Shreveport, Louisiana, 71118

    Recruiting

  • HonorHealth Cancer Care - Tempe - AZCCC Imaging

    Tempe, Arizona, 85284

    Recruiting

  • HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe

    Tempe, Arizona, 85284

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

    Recruiting

  • MD Anderson Cancer Center at Cooper

    Voorhees Township, New Jersey, 08043

    Recruiting

  • Texas Oncology - Central South

    Waco, Texas, 76712

    Recruiting

  • Florida Cancer Specialists

    Wellington, Florida, 33414

    Recruiting

  • Texas Oncology - Central South

    Weslaco, Texas, 78596

    Recruiting

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

    Recruiting

  • SCC at St. John's Medical Center

    Westlake, Ohio, 44145

    Recruiting

  • M Healt Fairview - Woodwinds Hospital

    Woodbury, Minnesota, 55125

    Recruiting

Other trials in United States

Puerto Rico1 site, 1 recruiting

  • Puerto Rico Cancer Specialists Clinical Trials

    San Juan, 00917-5027

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.

  • This study is seeking for participants who: Are willing to take all the required eye tests
  • Have not received TIVDAK before
  • Do not have any active eye issues.
Read more

Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:

  • before starting the treatment,
  • before each of the first 9 infusions
  • then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.
Conditions
Cervical Cancer
Being tested
TIVDAK
Keywords
Uterine Neoplasms, Genital Neoplasms, Female Urogenital Neoplasms, Neoplasms by Site, Neoplasms Uterine, Cervical Diseases, Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Genital Diseases Uterine Cervical Neoplasms,, Tisotumab vedotin
Medical subject headings
Uterine Cervical Neoplasms, Uterine Neoplasms, Neoplasms by Site, Uterine Cervical Diseases, Uterine Diseases, Genital Diseases, Female, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIVDAKDrug

    2 mg/kg once every 3 weeks (Q3W)

Study groups in NCT06952660
Study groupRoleWhat they receive
Tisotumab vedotinExperimentalParticipants will receive tisotumab vedotin by IV infusion.
Receives: Drug: TIVDAK

What is being measured

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

  1. Type, incidence and severity of ocular adverse events (AEs)

    Measured: 90 days after the last dose of tisotumab vedotin

Secondary outcomes (4)

  1. Time to resolution of ocular AEs

    Measured: 90 days after the last dose of tisotumab vedotin

  2. Time to onset of ocular AEs

    Measured: 90 days after the last dose of tisotumab vedotin

  3. Incidence of serious adverse events (SAEs)

    Measured: 90 days after the last dose of tisotumab vedotin

  4. AEs leading to dose modifications including treatment discontinuation

    Measured: 90 days after the last dose of tisotumab vedotin

Timeline

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

  1. First posted1 May 2025
  2. Study start7 May 2025
  3. Primary completion13 Dec 2028 (estimated)
  4. Study completion13 Dec 2028 (estimated)

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06952660
Sponsor's protocol ID
C5721005
Status last verified
Nov 2026
First submitted
15 Apr 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TIVDAK in people with Cervical Cancer, run by Pfizer at 135 sites in 2 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Puerto Rico. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type, incidence and severity of ocular adverse events (AEs) (time frame: 90 days after the last dose of tisotumab vedotin). 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 NCT06952660.

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 5 Nov 2026.

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