A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
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.
Arms & interventions
- DrugTIVDAK
2 mg/kg once every 3 weeks (Q3W)
Outcome measures
Primary
Type, incidence and severity of ocular adverse events (AEs)
Time frame: 90 days after the last dose of tisotumab vedotin
Secondary
Time to resolution of ocular AEs
Time frame: 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
Incidence of serious adverse events (SAEs)
Time frame: 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
Eligibility criteria
Study locations (92)
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona, 85016
HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona, 85016
Sonora Quest Laboratories, LLC
Phoenix, Arizona, 85034
South West Medical Imaging (SMIL)
Phoenix, Arizona, 85258
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260
Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona, 85260
HonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona, 85284
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura, Florida, 33180
Florida Cancer Specialists
Bonita Springs, Florida, 34135
Florida Cancer Specialists
Bradenton, Florida, 34211
Florida Cancer Specialists
Cape Coral, Florida, 33909
Broward Health Coral Springs
Coral Springs, Florida, 33065
Florida Cancer Specialists
Daytona Beach, Florida, 32117
Broward Health North
Deerfield Beach, Florida, 33064
Florida Cancer Specialists
Fleming Island, Florida, 32003
Broward Health Imperial Point
Fort Lauderdale, Florida, 33308
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Florida Cancer Specialists
Fort Myers, Florida, 33905
Florida Cancer Specialists
Fort Myers, Florida, 33908
HCA Mercy Hospital
Miami, Florida, 33133
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Mount Sinai Medical Center of Florida, Inc
Miami Beach, Florida, 33140
Florida Cancer Specialists
N. Venice, Florida, 34275
Florida Cancer Specialists
Naples, Florida, 34102
Orlando Health Cancer Institute
Orlando, Florida, 32806
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
Orlando Health Winnie Palmer Hospital for Women & Babies
Orlando, Florida, 32806
Florida Cancer Specialists
Port Charlotte, Florida, 33980
Florida Cancer Specialists
Sarasota, Florida, 34236
Florida Cancer Specialists
Stuart, Florida, 34994
Florida Cancer Specialists
Wellington, Florida, 33414
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303
Grady Memorial Hospital Investigational Drug Service
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
Winship Cancer Institute
Atlanta, Georgia, 30322
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
Rush University Medical Center
Chicago, Illinois, 60607
Rush University Medical Center, Ophthalmology
Chicago, Illinois, 60612
Illinois Eye Center
Peoria, Illinois, 61615
OSF Saint Francis Medical Center (OSF SFMC)
Peoria, Illinois, 61637
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202
Norton Hospital
Louisville, Kentucky, 40202
Norton Cancer Institute St Matthews Campus
Louisville, Kentucky, 40207
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
University Medical Center - New Orleans
New Orleans, Louisiana, 70112
Trials365, LLC
Shreveport, Louisiana, 71103
Willis Knighton Cancer Center
Shreveport, Louisiana, 71103
Willis Knighton Physician Network - Hematology/Oncology
Shreveport, Louisiana, 71103
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71103
WK Eye Institute North
Shreveport, Louisiana, 71103
Willis Knighton Physician Network/Gynecologic Oncology Associates
Shreveport, Louisiana, 71118
M Health Fairview Clinics and Specialty Center
Burnsville, Minnesota, 55337
M Health Fairview Clinics and Surgery Center
Edina, Minnesota, 55435
M Health Fairview Clinics and Surgery Center
Maple Grove, Minnesota, 55369
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
M Healt Fairview - Woodwinds Hospital
Woodbury, Minnesota, 55125
St. Dominic - Jackson Memorial Hospital
Jackson, Mississippi, 39216
St. Dominic Gynecologic Oncology
Jackson, Mississippi, 39216
Intermountain Health Saint Vincent Regional Hospital
Billings, Montana, 59101
Saint Vincent Regional Hospital- Cancer Centers of Montana
Billings, Montana, 59102
Yellowstone Eye Care
Billings, Montana, 59102
Intermountain Health West End Clinic- Gynecologic Oncology
Billings, Montana, 59106
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
MD Anderson Cancer Center at Cooper
Voorhees Township, New Jersey, 08043
Maimonides Medical Center
Brooklyn, New York, 11220
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, 10032
IP Address: Columbia University Medical Center/New York Presbyterian Hospital Research Pharmacy
New York, New York, 10032
Miami Valley Hospital South
Centerville, Ohio, 45459
Kettering Health Cancer Center
Kettering, Ohio, 45429
Kettering Health Main Campus
Kettering, Ohio, 45429
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, 74146
Women & Infants Hospital of Rhode Island/The Program in Women´s Oncology - Clinic
Providence, Rhode Island, 02905
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Texas Oncology - Central South
Austin, Texas, 78731
Texas Oncology - Central South
Austin, Texas, 78745
Texas Oncology - Central South
Austin, Texas, 78758
Texas Oncology - Central South
Harlingen, Texas, 78550
Texas Oncology - Central South
McAllen, Texas, 78503
Texas Oncology - Central South
Waco, Texas, 76712
Texas Oncology - Central South
Weslaco, Texas, 78596
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University of Virginia
Charlottesville, Virginia, 22908
UVA Health Cancer Care Pantops
Charlottesville, Virginia, 22911
Carilion Clinic Gynecologic Oncology
Roanoke, Virginia, 24016