If you have cervical cancer that has progressed after treatment with chemotherapy or stopped responding to chemotherapy, consider joining a clinical trial of an approved treatment option.
Tivdak® (tisotumab vedotin-tftv) is a prescription medicine used to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have received chemotherapy that did not work or is no longer working.
Eye problems are common with Tivdak® and can be severe. Tivdak® can cause changes to the surface of your eye that can lead to dry eyes, eye redness, eye irritation, corneal ulcers, blurred vision, and severe vision loss. In most patients, eye problems are mild and manageable. The study doctor will discuss this with you in more detail.
This clinical trial will help us learn more about potential eye problems in women receiving Tivdak® for cervical cancer that has returned or spread to other parts of the body.
Who may participate
Joining a clinical trial is an important and personal decision. Thank you for considering participation.
This clinical trial may be an option if:
- You are at least 18 years of age
- You have cervical cancer that has returned (recurrent) or spread to other parts of the body (metastasized) during or after chemotherapy
- Your doctor has decided that Tivdak® is an option for you
- You have not previously received treatment with Tivdak®
There are other requirements for taking part in this clinical trial. The study doctor will explain these to you if you’d like to learn more. To see if you may qualify, click “Get Started.”
Condition
Recurrent metastatic cervical cancer
Age
18+ years
Medical history
Eligible to receive Tivdak® according to US Prescribing Information
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If this clinical trial is a good fit for you and you decide to take part, you will receive intravenous (IV) infusions of Tivdak® every 3 weeks as part of your normal treatment plan until your cancer progresses or you decide to stop treatment.
An eye doctor will examine your eyes before each of your first 9 infusions, and then once a month for 90 days after your last infusion.
To reduce the risk of eye problems, you will follow an eye care plan consistent with US Prescribing Information for Tivdak®. You will need to use 3 different types of eye drops and place a cold pack over your eyes during each infusion. The study doctor will provide more information about how to care for your eyes.
Length of study treatment
Up to 3 months after last infusion of Tivdak®
Number of study visits
Varies based on number of Tivdak® infusions
Long-term follow up
3 months
About Tivdak®
Tivdak® is a type of medicine called an antibody-drug conjugate (ADC), which is thought to work by attaching to a protein found on certain types of cancer cells. It has been approved by the United States Food and Drug Administration (FDA) to treat adults with cervical cancer that has returned or has spread to other parts of the body, and who have received chemotherapy that did not work or is no longer working.
In a previous phase 3 study (innovaTV 301), patients with recurrent or metastatic cervical cancer who received Tivdak® lived longer than those who received chemotherapy.1
For more information about Tivdak®, including previous clinical trial results and safety information, visit Tivdak.com.
1. Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301). ClinicalTrials.gov identifier: NCT04697628. Updated March 12, 2025. Accessed April 8, 2025. https://clinicaltrials.gov/study/NCT04697628
Participation matters
It’s important to continue research that may improve care for women with cervical cancer. The greater the diversity among clinical trial participants, the more we can learn about how treatments work in the real world. Participation by women of all backgrounds will enable us to get a fuller picture of how Tivdak® affects different types of people.
Frequently asked questions
There is no cost to participate for participants in this clinical trial. You will be reimbursed for study-related expenses such as travel, parking, childcare and meals.
Participating in a clinical trial is your choice. You can choose to leave the clinical trial at any time, for any reason, and your regular medical care will not be affected.
If you choose to join this clinical trial, you will receive Tivdak® according to approved treatment guidelines while contributing to research that could help thousands of other women around the world. Standard treatment with Tivdak® includes an eye care plan and eye exams prior to each of your first 9 infusions. An additional requirement of this study is to attend up to 3 monthly eye exams after your last infusion.
Your eyes will be carefully monitored during your time in the clinical trial. The study doctor may adjust, pause, or stop your treatment if you have new or worsening side effects.
