Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIVDAK.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug TIVDAK
2 mg/kg once every 3 weeks (Q3W)
Primary outcome measures
- Type, incidence and severity of ocular adverse events (AEs) [Time frame: 90 days after the last dose of tisotumab vedotin]
Secondary outcome measures (4)
- Time to resolution of ocular AEs [Time frame: 90 days after the last dose of tisotumab vedotin]
- Time to onset of ocular AEs [Time frame: 90 days after the last dose of tisotumab vedotin]
- Incidence of serious adverse events (SAEs) [Time frame: 90 days after the last dose of tisotumab vedotin]
- AEs leading to dose modifications including treatment discontinuation [Time frame: 90 days after the last dose of tisotumab vedotin]
Eligibility criteria
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'
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 128 centers
- HonorHealth Cancer Care - Biltmore - AZCCC Imaging — Phoenix
- HonorHealth Cancer Care - Biltmore - HonorHealth Research Pharmacy — Phoenix
- HonorHealth Research Institute (Arizona Center for Cancer Care) - HonorHealth Cancer Care — Phoenix
- Sonora Quest Laboratories, LLC — Phoenix
- South West Medical Imaging (SMIL) — Phoenix
- Schwartz Laser Eye Center — Scottsdale
- Virginia G. Piper Cancer Pharmacy - HonorHealth Research Pharmacy — Scottsdale
- HonorHealth Cancer Care - Tempe - AZCCC Imaging — Tempe
- … and 120 more centers
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06952660 · C5721005