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Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Sponsor: Pfizer
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-05-07
Completion Date
2028-12-13
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
TIVDAK
2 mg/kg once every 3 weeks (Q3W)
Locations (78)
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Florida Cancer Specialists
Cape Coral, Florida, United States
Broward Health Coral Springs
Coral Springs, Florida, United States
Florida Cancer Specialists
Daytona Beach, Florida, United States
Broward Health North
Deerfield Beach, Florida, United States
Florida Cancer Specialists
Fleming Island, Florida, United States
Broward Health Imperial Point
Fort Lauderdale, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
HCA Mercy Hospital
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, United States
Florida Cancer Specialists
N. Venice, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
Stuart, Florida, United States
Florida Cancer Specialists
Wellington, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Rush University Medical Center, Ophthalmology
Chicago, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Norton Cancer Institute St Matthews Campus
Louisville, Kentucky, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
University Medical Center - New Orleans
New Orleans, Louisiana, United States
Trials365, LLC
Shreveport, Louisiana, United States
Willis Knighton Cancer Center
Shreveport, Louisiana, United States
Willis Knighton Physician Network - Hematology/Oncology
Shreveport, Louisiana, United States
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, United States
WK Eye Institute North
Shreveport, Louisiana, United States
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, United States
M Health Fairview Clinics and Specialty Center
Burnsville, Minnesota, United States
M Health Fairview Clinics and Surgery Center
Edina, Minnesota, United States
M Health Fairview Clinics and Surgery Center
Maple Grove, Minnesota, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, United States
M Healt Fairview - Woodwinds Hospital
Woodbury, Minnesota, United States
St. Dominic - Jackson Memorial Hospital
Jackson, Mississippi, United States
St. Dominic Gynecologic Oncology
Jackson, Mississippi, United States
Intermountain Health Saint Vincent Regional Hospital
Billings, Montana, United States
Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings, Montana, United States
Yellowstone Eye Care
Billings, Montana, United States
Intermountain Health West End Clinic- Gynecologic Oncology
Billings, Montana, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Kettering Health Cancer Center
Kettering, Ohio, United States
Kettering Health Main Campus
Kettering, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Women & Infant´s Hospital Infusion Center
Providence, Rhode Island, United States
Texas Oncology - Central South
Austin, Texas, United States
Texas Oncology - Central South
Austin, Texas, United States
Texas Oncology - Central South
Austin, Texas, United States
Texas Oncology - Central South
Harlingen, Texas, United States
Texas Oncology - Central South
McAllen, Texas, United States
Texas Oncology - Central South
Waco, Texas, United States
Texas Oncology - Central South
Weslaco, Texas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
University of Virginia
Charlottesville, Virginia, United States
UVA Health Cancer Care Pantops
Charlottesville, Virginia, United States
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, United States
Puerto Rico Cancer Specialists Clinical Trials
San Juan, Puerto Rico