A Prospective Low-Interventional Phase 4 Single Arm Study of Ocular Assessments in Patients Treated with Tivdak® in Recurrent or Metastatic Cervical Cancer

Study of Eye Health in Patients Using a Medication Being Studied for Cervical Cancer

S
Sharon E. Robertson

Primary Investigator

Recruiting
18 years - 100 years
Female
Phase N/A
1 participants needed
2 Locations

Brief description of study

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.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cervical Cancer
  • Age: 18 years - 100 years
  • Gender: Female

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'

This study investigates the effects of an investigational medication on eye health in patients with recurrent or metastatic cervical cancer. Cervical cancer occurs when cells in the cervix grow uncontrollably. This study focuses on understanding any side effects related to the eyes that may arise from the treatment. A side effect is a reaction that occurs from a medication that is not related to its intended purpose.

Participants in this study will receive an infusion of the investigational medication once every three weeks. They will visit an eye care provider before starting the treatment, before each of the first nine infusions, and then monthly for three months after stopping the treatment. The treatment will continue as long as it is effective against the cancer.

  • Who can participate: Participants must have recurrent or metastatic cervical cancer and have previously received chemotherapy. They should not have active eye issues and must not have been treated with the medication being studied before.
  • Study details: Participants will receive the medication being studied through an infusion every three weeks. Regular eye exams will be conducted to monitor for any side effects related to the eyes.
  • Study visits: The study requires 12 visits.
Updated on 02 Dec 2025. Study ID: CTO-GOG-3116, 27226

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