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Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Trial Status: active
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.
Inclusion Criteria
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
Must agree to use effective contraception according to the US Prescribing Information
Exclusion Criteria
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'
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06952660.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Georgia
Atlanta
Grady Health System
Status: Active
Name Not Available
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Status: Active
Name Not Available
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
