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
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
Treatments tested in this trial
- TIVDAK
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Pfizer
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov