Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

Официальное название

A Phase 2, Multicenter, Single-Arm Study of Belvarafenib (HM95573) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma

Обзор

This is a Phase 2 open-label, multicenter, single-arm study evaluating the combination of Belvarafenib and Cobimetinib in patients with locally advanced or metastatic melanoma with NRAS mutations. The study plans to assess ORR, DCR, DOR, TTP, PFS, OS and safety of the participating subjects. Treatment cycles for all subjects will be 28 days in duration and Belvarafenib and Cobimetinib will be administered orally in combination.

Вмешательства

• Препарат Belvarafenib
  Belvarafenib will be taken twice daily (BID) on Days 1-28 of each cycle
• Комбинированный продукт Cobimetinib
  Cobimetinib will be taken on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of each cycle (three times weekly, TIW), followed by a drug holiday through Day 28

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]

Вторичные конечные точки (5)

• Disease Control Rate (DCR) [Срок оценки: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
• Duration of response (DOR) [Срок оценки: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
• Progression-free survival (PFS) [Срок оценки: Throughout the study until disease progression or death whichever occurs first (up to approximately 3 years)]
• Time to progression (TTP) [Срок оценки: Throughout the study until disease progression (up to approximately 3 years)]
• Overall survival (OS) [Срок оценки: Throughout the study until the date of death (up to approximately 3 years)]

Критерии участия

Критерии включения

• Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated.
• Have NRAS mutation.
• Have at least one measurable lesion at baseline per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Age of 19 years or older
• Adequate renal, hematologic and liver function.

Критерии исключения

• Have a history of prior treatment with RAF, MEK, or ERK inhibitor.
• Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO.
• Have past history or ongoing cardiac function-related disorders.
• Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).

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

Лечение

Центры проведения

South Korea · 10 центров

• Seoul National University Bundang Hospital — Seongnam-si
• Chonnam National University Hwasun Hospital — Hwasun
• Dong-A University Medical Center — Busan
• Kyungpook National University Chilgok Hospital — Daegu
• Chungnam National University Hospital — Daejeon
• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• Asan Medical Center — Seoul
• … и ещё 2 центра

Идентификаторы

NCT: NCT07449754 · HM-RAFI-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗