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NCT Number: NCT06952660

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

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.

Recruiting

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Puerto Rico Cancer Specialists Clinical Trials, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
  • Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
  • 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
  • Must agree to use effective contraception according to the US Prescribing Information

Exclusion criteria

  • Active ocular disease at baseline per investigator assessment
  • Previous treatment with Tivdak
  • Previous administration of an investigational drug within 30 days
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'

Treatment and study plan

TIVDAK

Drug

2 mg/kg once every 3 weeks (Q3W)

Primary outcomes

  1. Type, incidence and severity of ocular adverse events (AEs)

    Time frame: 90 days after the last dose of tisotumab vedotin

Secondary outcomes

  1. Time to resolution of ocular AEs

    Time frame: 90 days after the last dose of tisotumab vedotin

  2. Time to onset of ocular AEs

    Time frame: 90 days after the last dose of tisotumab vedotin

  3. Incidence of serious adverse events (SAEs)

    Time frame: 90 days after the last dose of tisotumab vedotin

  4. AEs leading to dose modifications including treatment discontinuation

    Time frame: 90 days after the last dose of tisotumab vedotin

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Genmab

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 1, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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