Clinical trial NCT06952660: Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Official title: A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cervical Cancer
Keywords: Uterine Neoplasms
Genital Neoplasms
Female Urogenital Neoplasms
Neoplasms by Site
Neoplasms Uterine
Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases Uterine Cervical Neoplasms,
Tisotumab vedotin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Genmab
First posted: 2025-05-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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's judgment, increase the risk of study participation or make the participant inappropriate for the study.
5. Patients who are breastfeeding, pregnant, or planning to become pregnant based on criteria as indicated in the US Prescribing Information
6. Known allergies, hypersensitivity, or intolerance to Tivdak or its excipients

Primary outcomes:
measure: Type, incidence and severity of ocular adverse events (AEs)
timeFrame: 90 days after the last dose of tisotumab vedotin
Secondary outcomes:
measure: Time to resolution of ocular AEs
timeFrame: 90 days after the last dose of tisotumab vedotin
measure: Time to onset of ocular AEs
timeFrame: 90 days after the last dose of tisotumab vedotin
measure: Incidence of serious adverse events (SAEs)
timeFrame: 90 days after the last dose of tisotumab vedotin
measure: AEs leading to dose modifications including treatment discontinuation
timeFrame: 90 days after the last dose of tisotumab vedotin
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Trials365, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Physician Network - Hematology/Oncology
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Physician Network/Gynecologic Oncology Associates
state: Louisiana
city: Shreveport
country: United States
facility: WK Eye Institute North
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Physician Network/Gynecologic Oncology Associates
state: Louisiana
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: