Clinical Trial Title
A prospective low-interventional phase 4 single arm study of ocular assessments in patients treated with Tivdak® in recurrent or metastatic cervical cancerNational Clinical Trial Number:
NCT06952660Contact Information
Clinical Trial Protocol Description:
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
- 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.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
- Your treating doctor has determined that treatment with Tivdak is appropriate for you.
- Are willing to undergo repeated eye exams as required by the study and regular clinic visits at Rush.
- Agree to use effective contraception according to the US Prescribing Information.
You will be excluded from the study if any of the following criteria apply to you:
- Have active ocular (eye) disease at baseline (normally).
- Have had previous treatment with Tivdak.
- Have had previous administration of an investigational drug within 30 days.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.