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

StatusRecruiting
PhasePhase 4
SponsorPfizer
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Study sites: 130 to 132
    • Eligibility criteria expanded, about 9 words
  3. Study sites: 129 to 130v15
  4. Re-verified, no change to tracked fieldsv14
  5. Trial sites expanded: 93 → 129 locationsv13
  6. Trial sites expanded: 78 → 93 locationsv12
  7. Study sites: 65 to 78v11
  8. Study sites: 42 to 65v10
  9. Study sites: 25 to 42v9
  10. Site details revised at 13 of 25 sitesv8
  11. Study sites: 22 to 25
    • Eligibility criteria shortened, about 45 words
    v7
  12. Study sites: 19 to 22v6
  13. Study sites: 15 to 19v5
  14. Study sites: 8 to 15v4
  15. Study sites: 7 to 8
    • Study title shortened, about 3 words
    v3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of May 9, 2025 to May 7, 2025
    v2
  17. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
441 trials monitored
See 30 trials at risk
Cervical Cancer
922 trials monitored
See 50 trials at risk
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.
Trial Details
NCT Number NCT06952660
Lead Sponsor Pfizer
Collaborators: Genmab
Conditions
(from sponsor)		 Cervical Cancer
Related terms Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Genital Diseases, Female, Neoplasms by Site, Urogenital Diseases, Uterine Cervical Diseases, Uterine Cervical Neoplasms, Uterine Diseases, Uterine Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov