Eye Health Monitoring in Patients Using Tivdak® for Recurrent or Metastatic Cervical Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT06952660
This study is focused on understanding the potential eye-related side effects of Tivdak, a treatment for cervical cancer that has returned or spread after chemotherapy. Participants will undergo regular eye exams to monitor any changes during and after treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
Tivdak is a medication used to treat cervical cancer that has come back or spread after chemotherapy. Chemotherapy is a treatment that uses drugs to stop cancer cells from growing or to kill them. This study aims to learn about any possible side effects of Tivdak, especially those affecting the eyes. Side effects are any unexpected reactions your body might have to a medication. Participants will receive Tivdak through an infusion into a vein every three weeks. They will have eye exams at three different times: before starting treatment, before each of the first nine infusions, and monthly for three months after stopping Tivdak. Treatment will continue as long as it is effective against the cancer.
Eligibility Criteria
Inclusion Criteria
- Have cervical cancer that has returned or spread after chemotherapy.
- Doctor has decided that Tivdak is a suitable treatment.
- Willing to sign a consent form to participate in the study.
- Agree to regular eye exams and clinic visits as part of the study.
- Agree to use effective birth control during the study.
Exclusion Criteria
- Have active eye disease at the start of the study.
- Have been treated with Tivdak before.
- Have taken an experimental drug in the last 30 days.
- Have any medical or mental health condition, including recent or active thoughts of self-harm, that might interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mount Sinai Comprehensive Cancer Center - Aventura | 33180 | Aventura | Florida |
| Broward Health Coral Springs | 33065 | Coral Springs | Florida |
| Broward Health North | 33064 | Deerfield Beach | Florida |
| Broward Health Imperial Point | 33308 | Fort Lauderdale | Florida |
| Broward Health Medical Center | 33316 | Fort Lauderdale | Florida |
| HCA Mercy Hospital | 33133 | Miami | Florida |
| Mount Sinai Comprehensive Cancer Center | 33140 | Miami Beach | Florida |
| Mount Sinai Medical Center of Florida, Inc | 33140 | Miami Beach | Florida |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
| Orlando Health Orlando Regional Medical Center | 32806 | Orlando | Florida |
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