Study of Eye Health During Treatment With TIVDAK for Recurrent or Metastatic Cervical Cancer

What this Trial Is About

Researchers are evaluating the side effects of TIVDAK, a drug used to treat cervical cancer that has returned or spread after chemotherapy. The study focuses particularly on eye-related side effects, aiming to understand their type, frequency, and severity in patients receiving this treatment. This is a Phase 4, single-arm study conducted to gather detailed safety information about TIVDAK in this patient group. Participants will receive TIVDAK as an intravenous infusion at a dose of 2 mgkg every three weeks. Treatment will continue until the drug no longer works against the cancer. Eye exams will be performed before starting treatment, before each of the first nine infusions, and then monthly for three months after stopping TIVDAK. These visits help monitor any eye-related side effects that may develop. During the study, participants will attend regular clinic visits for eye assessments and treatment. Researchers will track the type, incidence, and severity of eye-related adverse events up to 90 days after the last dose of TIVDAK. They will also monitor how long these side effects last, when they begin, and any serious adverse events or dose changes caused by side effects. The total duration of participation depends on treatment continuation and follow-up assessments after treatment ends.

Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer