A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Mount Sinai Comprehensive Cancer Center - Aventura
RECRUITING
Aventura
Broward Health Coral Springs
RECRUITING
Coral Springs
Broward Health North
RECRUITING
Deerfield Beach
Broward Health Imperial Point
RECRUITING
Fort Lauderdale
Broward Health Medical Center
RECRUITING
Fort Lauderdale
HCA Mercy Hospital
RECRUITING
Miami
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Mount Sinai Medical Center of Florida, Inc
RECRUITING
Miami Beach
Orlando Health Cancer Institute
RECRUITING
Orlando
Orlando Health Orlando Regional Medical Center
RECRUITING
Orlando
Orlando Health Winnie Palmer Hospital for Women & Babies