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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TIVDAK
  2 mg/kg once every 3 weeks (Q3W)

Первичные конечные точки

• Type, incidence and severity of ocular adverse events (AEs) [Срок оценки: 90 days after the last dose of tisotumab vedotin]

Вторичные конечные точки (4)

• Time to resolution of ocular AEs [Срок оценки: 90 days after the last dose of tisotumab vedotin]
• Time to onset of ocular AEs [Срок оценки: 90 days after the last dose of tisotumab vedotin]
• Incidence of serious adverse events (SAEs) [Срок оценки: 90 days after the last dose of tisotumab vedotin]
• AEs leading to dose modifications including treatment discontinuation [Срок оценки: 90 days after the last dose of tisotumab vedotin]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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'

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 128 центров

• 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
• … и ещё 120 центров

Пуэрто-Рико · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06952660 · C5721005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗