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

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

Status
Active
Cancer Type
Cervical Cancer
Trial Phase
Phase IV
Eligibility
18 Years and older, Male and Female
Study Type
Other
NCT ID
NCT06952660
Protocol IDs
C5721005 (primary)
NCI-2025-05282
Study Sponsor
Pfizer Inc

Summary

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.

Eligibility

  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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.