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

Condition(s) studied

Investigational drug(s) / intervention(s)

TIVDAK: 2 mg/kg once every 3 weeks (Q3W)

Study 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

Primary outcome measure(s)

• Type, incidence and severity of ocular adverse events (AEs) — 90 days after the last dose of tisotumab vedotin

Trial sites (130)

+ 90 more sites — see the full list on the official registry below.