Evaluation of ocular safety in patients treated with Tivdak® in recurrent or metastatic cervical cancer
Tisotumab vedotin-tftv (Tivdak®) is an FDA-approved treatment recommended by the National Comprehensive Cancer Network (NCCN) as a Category 1 preferred option for second-line or subsequent therapy for recurrent or metastatic cervical cancer (r/mCC).1 Tivdak® can cause severe ocular adverse reactions, including conjunctivitis, keratopathy, and dry eye that may lead to changes in vision and/or corneal ulceration.
Pfizer and Genmab’s C5721005/GOG-3116 clinical trial is a post-authorization safety study to further characterize the incidence and severity of Tivdak®-related ocular events with prospectively prespecified,scheduled ocular assessments in adults with r/mCC.
Who can participate
Your patients may qualify if they:
Are at least 18 years of age
Your patients may qualify if they:
Have r/mCC with disease progression on or after chemotherapy
Your patients may qualify if they:
Are appropriate for treatment with Tivdak® according to US Prescribing Information
Your patients may qualify if they:
Have not previously received treatment with Tivdak®
Additional requirements apply.
Only Principal Investigators can determine eligibility.
Participants will receive Tivdak® 2 mg/kg once every 3 weeks via IV infusion as part of routine treatment consistent with approved US Prescribing Information, including required eye care and ocular assessments prior to each of their first 9 doses or as clinically indicated. Additionally, participants will have monthly ocular assessments for 90 days following their last dose of Tivdak® to facilitate collection of adverse event improvement and resolution data per study protocol.
Tivdak must be prescribed to participants under routine care and will not be provided as a study intervention. Participants will receive ocular assessments and eye drops at no cost and may receive a stipend for attending study-related visits, including ophthalmic exams. Participants may also receive reimbursement for study-related expenses such as travel, parking, and childcare.
Tisotumab vedotin–tftv (Tivdak®) is a tissue factor-directed antibodydrug-conjugate (ADC) approved in the United States for the treatment of adult patients with r/mCC with disease progression on or after chemotherapy.
A previous phase 3, global clinical trial (innovaTV301; NCT04697628) demonstrated that treatment with Tivdak® provides significantly improved efficacy compared to single agent chemotherapy in patients with previously treated r/mCC. Ocular adverse events occurred in approximately half of participants treated with Tivdak®. The safety profile of Tivdak® was manageable and consistent with previous experience across clinical studies.2
For more information about Tivdak®, including previous clinical trial results and safety information, visit [TivdakHCP.com].
Get started
Answer a 2-minute questionnaire and speak to a study representative.
The first step as you consider connecting with a Principal Investigator is to answer a 2-minute online questionnaire. If your answers indicate that the clinical trial may be a good fit for your patient(s), you can choose to share your contact information with a selected clinical trial site.
Get connected.
Your answers to these questions will only be linked to you if you choose to share your contact information and indicate that you would like to be connected with a Principal Investigator. Pfizer team members and our partners will have access to reports containing aggregated data that will not be linked directly back to you.
People are often introduced to clinical trials through conversations with their healthcare providers. We appreciate you taking the time to have discussions with your patients and their loved ones who may be interested in contributing to research.
Should any of your patients take part in this clinical trial, they will have the option to remain under your medical care for all non-study-related needs.
Thank you for considering your patients for this important clinical trial.
References
1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cervical Cancer V.3.2025. National Comprehensive Cancer Network, Inc. 2025. Accessed February 11, 2025. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1426
2. Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV301). ClinicalTrials.gov identifier: NCT04697628. Updated March 12, 2025. Accessed April 8, 2025. https://clinicaltrials.gov/study/NCT04697628