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

April 17, 2026 updated by: Pfizer

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00917-5027
        • Recruiting
        • Puerto Rico Cancer Specialists Clinical Trials
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • HonorHealth Cancer Care - Biltmore - AZCCC Imaging
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
      • Phoenix, Arizona, United States, 85034
        • Recruiting
        • Sonora Quest Laboratories, LLC
      • Phoenix, Arizona, United States, 85258
        • Recruiting
        • South West Medical Imaging (SMIL)
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Schwartz Laser Eye Center
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
      • Tempe, Arizona, United States, 85284
        • Recruiting
        • HonorHealth Cancer Care - Tempe - AZCCC Imaging
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center - Aventura
      • Bonita Springs, Florida, United States, 34135
        • Recruiting
        • Florida Cancer Specialists
      • Bradenton, Florida, United States, 34211
        • Recruiting
        • Florida Cancer Specialists
      • Cape Coral, Florida, United States, 33909
        • Recruiting
        • Florida Cancer Specialists
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • Broward Health Coral Springs
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Florida Cancer Specialists
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Broward Health North
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Florida Cancer Specialists
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Broward Health Imperial Point
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Florida Cancer Specialists
      • Fort Myers, Florida, United States, 33905
        • Recruiting
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33133
        • Recruiting
        • HCA Mercy Hospital
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center of Florida, Inc
      • N. Venice, Florida, United States, 34275
        • Recruiting
        • Florida Cancer Specialists
      • Naples, Florida, United States, 34102
        • Recruiting
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Orlando Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Winnie Palmer Hospital for Women & Babies
      • Port Charlotte, Florida, United States, 33980
        • Recruiting
        • Florida Cancer Specialists
      • Sarasota, Florida, United States, 34236
        • Recruiting
        • Florida Cancer Specialists
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Florida Cancer Specialists
      • Wellington, Florida, United States, 33414
        • Recruiting
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • The Emory Clinic
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System Correll Pavilion
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital Investigational Drug Service
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center, Ophthalmology
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Eye Center
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center (OSF SFMC)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health University Hospital
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Sidney & Lois Eskenazi Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute - Downtown
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Hospital
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Women's and Children's Hospital
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Cancer Institute St Matthews Campus
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center - New Orleans
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Trials365, LLC
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis Knighton Cancer Center
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis Knighton Physician Network - Hematology/Oncology
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis Knighton Physician Network/Gynecologic Oncology Associates
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • WK Eye Institute North
      • Shreveport, Louisiana, United States, 71118
        • Recruiting
        • Willis Knighton Physician Network/Gynecologic Oncology Associates
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • M Health Fairview Clinics and Specialty Center
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • M Health Fairview Clinics and Surgery Center
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • M Health Fairview Clinics and Surgery Center
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • M Health Fairview St. John's Hospital
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • M Health Fairview Clinics and Surgery Center
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • M Healt Fairview - Woodwinds Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • St. Dominic - Jackson Memorial Hospital
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • St. Dominic Gynecologic Oncology
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Intermountain Health Saint Vincent Regional Hospital
      • Billings, Montana, United States, 59102
        • Recruiting
        • Saint Vincent Regional Hospital- Cancer Centers of Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Yellowstone Eye Care
      • Billings, Montana, United States, 59106
        • Recruiting
        • Intermountain Health West End Clinic- Gynecologic Oncology
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Women's Cancer Center of Nevada
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • MD Anderson Cancer Center at Cooper
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • MD Anderson Cancer Center at Cooper
    • New York
      • Brooklyn, New York, United States, 11220
        • Recruiting
        • Maimonides Medical Center
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center - Herbert Irving Pavilion
      • New York, New York, United States, 10032
        • Not yet recruiting
        • IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health Cancer Center
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health Main Campus
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute, LLC
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital of Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78745
        • Recruiting
        • Texas Oncology - Central South
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Texas Oncology - Central South
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - Central South
      • Waco, Texas, United States, 76712
        • Recruiting
        • Texas Oncology - Central South
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Oncology - Central South
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Comprehensive Cancer Center
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • UVA Health Cancer Care Pantops
      • Roanoke, Virginia, United States, 24016
        • Recruiting
        • Carilion Clinic Gynecologic Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
  3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
  4. 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
  5. Must agree to use effective contraception according to the US Prescribing Information

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tisotumab vedotin
Participants will receive tisotumab vedotin by IV infusion.
Drug: TIVDAK
2 mg/kg once every 3 weeks (Q3W)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type, incidence and severity of ocular adverse events (AEs)
Time Frame: 90 days after the last dose of tisotumab vedotin
90 days after the last dose of tisotumab vedotin

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to resolution of ocular AEs
Time Frame: 90 days after the last dose of tisotumab vedotin
90 days after the last dose of tisotumab vedotin
Time to onset of ocular AEs
Time Frame: 90 days after the last dose of tisotumab vedotin
90 days after the last dose of tisotumab vedotin
Incidence of serious adverse events (SAEs)
Time Frame: 90 days after the last dose of tisotumab vedotin
90 days after the last dose of tisotumab vedotin
AEs leading to dose modifications including treatment discontinuation
Time Frame: 90 days after the last dose of tisotumab vedotin
90 days after the last dose of tisotumab vedotin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Genmab

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

December 13, 2028

Study Completion (Estimated)

December 13, 2028

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C5721005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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