Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)

Официальное название

A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Обзор

Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors: * Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids * VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.

Вмешательства

• Препарат Belzutifan
  Belzutifan is administered orally at 120 mg once daily (qd) OR 200 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
• Препарат Nivolumab
  Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
• Препарат Lenvatinib
  Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
• Препарат Cabozantinib
  Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Первичные конечные точки

• Cohort A and Cohort B: Overall Survival (OS) [Срок оценки: Up to approximately 7 years]

Вторичные конечные точки (2)

• Number of Participants Who Experience One or More Adverse Events (AE) [Срок оценки: Up to approximately 2 years]
• Number of Participants Who Discontinued Study Intervention Due to an AE [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable.
• Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Beth Israel Deaconess Medical Center ( Site 0107) — Boston
• Dana-Farber Cancer Institute ( Site 0105) — Boston
• Karmanos Cancer Center ( Site 0108) — Detroit
• Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 01 — Philadelphia
• SCRI Oncology Partners ( Site 7000) — Nashville
• START San Antonio ( Site 0104) — San Antonio
• Fred Hutchinson Cancer Center ( Site 0106) — Seattle

Чили · 6 центров

• James Lind Centro de Investigacion del Cancer ( Site 0304) — Temuco
• CIDO SpA ( Site 0305) — Temuco
• FALP ( Site 0300) — Santiago
• Oncovida ( Site 0303) — Santiago
• Bradfordhill ( Site 0301) — Santiago
• ONCOCENTRO APYS ( Site 0302) — Viña del Mar

Израиль · 5 центров

• Rambam Health Care Campus ( Site 1600) — Haifa
• Hadassah Medical Center ( Site 1604) — Jerusalem
• Rabin Medical Center ( Site 1602) — Petah Tikva
• Sheba Medical center ( Site 1601) — Ramat Gan
• Sourasky Medical Center ( Site 1603) — Tel Aviv

Великобритания · 5 центров

• The Beatson West of Scotland Cancer Centre ( Site 2505) — Glasgow
• St Bartholomew's Hospital ( Site 2500) — London
• ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502) — London
• Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504) — London
• The Christie NHS Foundation Trust ( Site 2501) — Manchester

South Korea · 3 центра

• Samsung Medical Center ( Site 2902) — Gangnam
• Severance Hospital, Yonsei University Health System ( Site 2901) — Seodaemun-gu
• Asan Medical Center ( Site 2900) — Seoul

Австралия · 2 центра

• St George Hospital-Oncology Clinical Research Unit ( Site 2701) — Kogarah
• Westmead Hospital ( Site 2703) — Sydney

Франция · 2 центра

• Hôpitaux Universitaires de Strasbourg ( Site 1702) — Strasbourg
• Institut Claudius Regaud ( Site 1703) — Toulouse

Нидерланды · 2 центра

• Maastricht Universitair Medisch Centrum - MUMC ( Site 1900) — Maastricht
• Isala, locatie Zwolle ( Site 1902) — Zwolle

Россия · 2 центра

• N.N. Blokhin NMRCO ( Site 2101) — Moscow
• Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100) — Saint Petersburg

Испания · 2 центра

• Hospital Universitari Vall d'Hebron ( Site 2300) — Barcelona
• Hospital Universitario 12 de Octubre ( Site 2301) — Madrid

Украина · 2 центра

• ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601) — Dnipropetrovsk
• CNCE Precarpathian Clinical Oncologic Center ( Site 2600) — Ivano-Frankivsk

Бельгия · 1 центр

• UZ Leuven ( Site 0900) — Leuven

Бразилия · 1 центр

• BP - A Beneficencia Portuguesa de São Paulo ( Site 0200) — São Paulo

Чехия · 1 центр

• Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) — Olomouc

Дания · 1 центр

• Herlev and Gentofte Hospital ( Site 1200) — Herlev

Финляндия · 1 центр

• Tampereen yliopistollinen sairaala ( Site 1305) — Tampere

Венгрия · 1 центр

• Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site — Budapest

Япония · 1 центр

• Kyushu University Hospital ( Site 3101) — Fukuoka

Новая Зеландия · 1 центр

• Auckland City Hospital ( Site 3000) — Auckland

Польша · 1 центр

• Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 2000) — Bydgoszcz

Тайвань · 1 центр

• Taipei Veterans General Hospital ( Site 2800) — Taipei

Идентификаторы

NCT: NCT07405164 · 6482-043 · U1111-1325-4582 · 2025-524160-38-00 · MK-6482-043 · jRCT2061260008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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