Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
1 other identifier
interventional
100
2 countries
93
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2025
Longer than P75 for phase_4
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedStudy Start
First participant enrolled
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 13, 2028
April 20, 2026
April 1, 2026
3.6 years
April 15, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Type, incidence and severity of ocular adverse events (AEs)
90 days after the last dose of tisotumab vedotin
Secondary Outcomes (4)
Time to resolution of ocular AEs
90 days after the last dose of tisotumab vedotin
Time to onset of ocular AEs
90 days after the last dose of tisotumab vedotin
Incidence of serious adverse events (SAEs)
90 days after the last dose of tisotumab vedotin
AEs leading to dose modifications including treatment discontinuation
90 days after the last dose of tisotumab vedotin
Study Arms (1)
Tisotumab vedotin
EXPERIMENTALParticipants will receive tisotumab vedotin by IV infusion.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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'
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona, 85016, United States
HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona, 85016, United States
Sonora Quest Laboratories, LLC
Phoenix, Arizona, 85034, United States
South West Medical Imaging (SMIL)
Phoenix, Arizona, 85258, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260, United States
Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona, 85260, United States
HonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona, 85284, United States
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34211, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
Broward Health Coral Springs
Coral Springs, Florida, 33065, United States
Florida Cancer Specialists
Daytona Beach, Florida, 32117, United States
Broward Health North
Deerfield Beach, Florida, 33064, United States
Florida Cancer Specialists
Fleming Island, Florida, 32003, United States
Broward Health Imperial Point
Fort Lauderdale, Florida, 33308, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
HCA Mercy Hospital
Miami, Florida, 33133, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, 33140, United States
Florida Cancer Specialists
N. Venice, Florida, 34275, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Stuart, Florida, 34994, United States
Florida Cancer Specialists
Wellington, Florida, 33414, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303, United States
Grady Memorial Hospital Investigational Drug Service
Atlanta, Georgia, 30303, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Rush University Medical Center
Chicago, Illinois, 60607, United States
Rush University Medical Center, Ophthalmology
Chicago, Illinois, 60612, United States
Illinois Eye Center
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois, 61637, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
Norton Cancer Institute St Matthews Campus
Louisville, Kentucky, 40207, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207, United States
University Medical Center - New Orleans
New Orleans, Louisiana, 70112, United States
Trials365, LLC
Shreveport, Louisiana, 71103, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
Willis Knighton Physician Network - Hematology/Oncology
Shreveport, Louisiana, 71103, United States
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71103, United States
WK Eye Institute North
Shreveport, Louisiana, 71103, United States
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71118, United States
M Health Fairview Clinics and Specialty Center
Burnsville, Minnesota, 55337, United States
M Health Fairview Clinics and Surgery Center
Edina, Minnesota, 55435, United States
M Health Fairview Clinics and Surgery Center
Maple Grove, Minnesota, 55369, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455, United States
M Healt Fairview - Woodwinds Hospital
Woodbury, Minnesota, 55125, United States
St. Dominic - Jackson Memorial Hospital
Jackson, Mississippi, 39216, United States
St. Dominic Gynecologic Oncology
Jackson, Mississippi, 39216, United States
Intermountain Health Saint Vincent Regional Hospital
Billings, Montana, 59101, United States
Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings, Montana, 59102, United States
Yellowstone Eye Care
Billings, Montana, 59102, United States
Intermountain Health West End Clinic- Gynecologic Oncology
Billings, Montana, 59106, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043, United States
Maimonides Medical Center
Brooklyn, New York, 11220, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032, United States
IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
New York, New York, 10032, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Kettering Health Cancer Center
Kettering, Ohio, 45429, United States
Kettering Health Main Campus
Kettering, Ohio, 45429, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146, United States
Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
Providence, Rhode Island, 02905, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Texas Oncology - Central South
Austin, Texas, 78731, United States
Texas Oncology - Central South
Austin, Texas, 78745, United States
Texas Oncology - Central South
Austin, Texas, 78758, United States
Texas Oncology - Central South
Harlingen, Texas, 78550, United States
Texas Oncology - Central South
McAllen, Texas, 78503, United States
Texas Oncology - Central South
Waco, Texas, 76712, United States
Texas Oncology - Central South
Weslaco, Texas, 78596, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
UVA Health Cancer Care Pantops
Charlottesville, Virginia, 22911, United States
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, 24016, United States
Puerto Rico Cancer Specialists Clinical Trials
San Juan, 00917-5027, Puerto Rico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
May 1, 2025
Study Start
May 7, 2025
Primary Completion (Estimated)
December 13, 2028
Study Completion (Estimated)
December 13, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.