Exploring TIVDAK for Women with Recurrent Cervical Cancer

A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER

Phase 4 Interventional Pfizer · NCT06952660

This study is testing a treatment called TIVDAK for women whose cervical cancer has come back after chemotherapy to see how it affects their health, especially their eyes.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexFemale
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy
Locations93 sites (Phoenix, Arizona and 92 other locations)
Trial IDNCT06952660 on ClinicalTrials.gov

What this trial studies

This study investigates the use of TIVDAK, a treatment for cervical cancer that has returned after chemotherapy. Participants will receive TIVDAK infusions every three weeks and undergo eye assessments at various stages throughout the treatment. The primary goal is to evaluate potential side effects, particularly those related to the eyes, in women with recurrent or metastatic cervical cancer. Participants must not have any active eye issues and must be willing to undergo the required ocular tests.

Who should consider this trial

Good fit: Ideal candidates are women with recurrent or metastatic cervical cancer who have experienced disease progression after chemotherapy and are willing to undergo eye assessments.

Not a fit: Patients with active ocular diseases or those who have previously received TIVDAK will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of TIVDAK for women with recurrent cervical cancer.

How similar studies have performed: Other studies have shown promise with TIVDAK in similar patient populations, indicating a potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria
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'

Where this trial is running

Phoenix, Arizona and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Cervical CancerUterine NeoplasmsGenital NeoplasmsFemale Urogenital NeoplasmsNeoplasms by SiteNeoplasms UterineCervical DiseasesUterine Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.