Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
- Registration Number
- NCT06952660
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tisotumab vedotin TIVDAK Participants will receive tisotumab vedotin by IV infusion.
- Primary Outcome Measures
Name Time Method Type, incidence and severity of ocular adverse events (AEs) 90 days after the last dose of tisotumab vedotin
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (24)
Mount Sinai Comprehensive Cancer Center - Aventura
🇺🇸Aventura, Florida, United States
Broward Health Coral Springs
🇺🇸Coral Springs, Florida, United States
Broward Health North
🇺🇸Deerfield Beach, Florida, United States
Broward Health Imperial Point
🇺🇸Fort Lauderdale, Florida, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, 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
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
Orlando Health Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Scroll for more (14 remaining)Mount Sinai Comprehensive Cancer Center - Aventura🇺🇸Aventura, Florida, United States