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

Launched by PFIZER · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on a treatment called TIVDAK for women with cervical cancer that has come back after chemotherapy. The main goal of the study is to learn more about any side effects of TIVDAK, particularly those related to the eyes. To participate, women need to have cervical cancer that has either returned or spread after chemotherapy, be in good eye health, and have not received TIVDAK before. Additionally, participants must be willing to undergo several eye tests throughout the study.

If you join the trial, you will receive TIVDAK through an infusion (an injection into the vein) once every three weeks. You will also visit an eye care provider for check-ups before starting treatment, before each of the first nine infusions, and monthly for three months after stopping TIVDAK. This is to closely monitor your eye health during the treatment. It's important to know that the study is not yet recruiting participants, but it is looking for women aged 65 to 74 who meet the eligibility criteria. If you are interested, you will need to sign a consent form explaining that you understand the study and agree to participate.

Gender

FEMALE

Eligibility criteria

• Inclusion criteria:
• • 1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
• • 2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
• • 3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
• • 4. 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
• • 5. Must agree to use effective contraception according to the US Prescribing Information
• Exclusion criteria:
• • 1. Active ocular disease at baseline per investigator assessment
• • 2. Previous treatment with Tivdak
• • 3. Previous administration of an investigational drug within 30 days
• • 4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator's judgment, increase the risk of study participation or make the participant inappropriate for the study.
• • 5. Patients who are breastfeeding, pregnant, or planning to become pregnant based on criteria as indicated in the US Prescribing Information
• • 6. Known allergies, hypersensitivity, or intolerance to Tivdak or its excipients