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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
100
2 mg/kg once every 3 weeks (Q3W)
HonorHealth Cancer Care - Biltmore - AZCCC Imaging
Phoenix, Arizona, United States
RECRUITINGHonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy
Phoenix, Arizona, United States
RECRUITINGHonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care -Biltmore
Phoenix, Arizona, United States
RECRUITINGSonora Quest Laboratories, LLC
Phoenix, Arizona, United States
Type, incidence and severity of ocular adverse events (AEs)
Time frame: 90 days after the last dose of tisotumab vedotin
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
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South West Medical Imaging (SMIL)
Phoenix, Arizona, United States
RECRUITINGSchwartz Laser Eye Center
Scottsdale, Arizona, United States
RECRUITINGVirginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy
Scottsdale, Arizona, United States
RECRUITINGHonorHealth Cancer Care - Tempe - AZCCC Imaging
Tempe, Arizona, United States
RECRUITINGHonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care - Tempe
Tempe, Arizona, United States
RECRUITINGCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
RECRUITING...and 122 more locations