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

ConditionCervical Cancer

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorPfizer

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active ocular disease at baseline per investigator assessment

Previous treatment with Tivdak

Previous administration of an investigational drug within 30 days

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Tisotumab vedotinExperimental treatment 1 intervention