A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

Официальное название

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

Обзор

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone. The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Вмешательства

• Препарат Belzutifan
  Tablet for oral administration.
• Препарат Zanzalintinib
  Tablet for oral administration.
• Препарат Placebo
  Zanzalintinib-matching placebo tablet for oral administration.

Первичные конечные точки

• Progression-free Survival (PFS) [Срок оценки: Up to approximately 30 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 50 months]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 30 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 30 months]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 25 months]
• Number of Participants who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 24 months]
• Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Срок оценки: Baseline and up to approximately 25 months]
• Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score [Срок оценки: Baseline and up to approximately 25 months]
• Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score [Срок оценки: Baseline and up to approximately 25 months]
• Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) (Items 1-9) Score [Срок оценки: Baseline and up to approximately 25 months]
• Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score [Срок оценки: Up to approximately 25 months]
• TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score [Срок оценки: Up to approximately 25 months]
• TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score [Срок оценки: Up to approximately 25 months]
• TTD in Disease Symptoms Using the FKSI-DRS (Items 1-9) Score [Срок оценки: Up to approximately 25 months]

Критерии участия

Критерии включения

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

• Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
• Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
• Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy

Критерии исключения

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

• Has any of the following: a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
• Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
• Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
• Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
• Has had major surgery within 8 weeks before randomization
• Has current pneumonitis/interstitial lung disease
• Has a history of human immunodeficiency virus infection
• Has Hepatitis B or Hepatitis C virus infection
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has a history of solid organ transplant
• Has not adequately recovered from major surgery or has ongoing surgical complications

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Аргентина · 9 центров

• Centro Oncologico Korben ( Site 0254) — CABA
• Hospital Italiano de Buenos Aires ( Site 0253) — Ciudad de Buenos Aires
• Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250) — Mar del Plata
• Centro Privado de RMI Río Cuarto S.A. II ( Site 0255) — Río Cuarto
• Sanatorio Parque ( Site 0251) — Rosario
• Instituto de Oncología de Rosario ( Site 0257) — Rosario
• Instituto Alexander Fleming ( Site 0252) — CABA
• Centro Oncológico Riojano Integral ( Site 0256) — La Rioja
• … и ещё 1 центр

Испания · 7 центров

• Hospital Universitario Virgen del Rocio ( Site 2306) — Seville
• Institut Català d'Oncologia - L'Hospitalet ( Site 2305) — L'Hospitalet de Llobregat
• HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301) — Madrid
• Hospital Universitari Vall d'Hebron ( Site 2303) — Barcelona
• Hospital Insular de Gran Canaria ( Site 2308) — Las Palmas
• Hospital Universitario 12 de Octubre ( Site 2300) — Madrid
• Fundación Instituto Valenciano de Oncología ( Site 2307) — Valencia

Франция · 6 центров

• Centre Antoine Lacassagne ( Site 1209) — Nice
• Hopital Europeen Marseille ( Site 1216) — Marseille
• LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215) — Toulouse
• CHU Angers ( Site 1204) — Angers
• Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203) — Le Mans
• CHU de Saint-Etienne ( Site 1202) — Saint Priest En Jarez

Италия · 6 центров

• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809) — Meldola
• Azienda Ospedaliera Universitaria Careggi ( Site 1807) — Florence
• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800) — Milan
• AO Santa Maria della Misericordia ( Site 1805) — Perugia
• Istituto Nazionale Tumori Regina Elena ( Site 1804) — Roma
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Польша · 5 центров

• AIDPORT Sp. z o.o. ( Site 2118) — Skórzewo
• Pratia MCM Krakow ( Site 2115) — Krakow
• Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102) — Siedlce
• MTZ Clinical Research Powered by Pratia ( Site 2107) — Warsaw
• Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106) — Gliwice

Turkey (Türkiye) · 5 центров

• Hacettepe Universite Hastaneleri ( Site 2500) — Sıhhiye
• Adana Medical Park Seyhan Hastanesi ( Site 2505) — Adana
• Ankara University Health Practice and Research Hospitals ( Site 2506) — Ankara
• Trakya University Medical Faculty Hospital ( Site 2502) — Edirne
• Koc Universitesi Hastanesi ( Site 2501) — Istanbul

Бразилия · 4 центра

• CEDOES ( Site 0303) — Vitória
• Instituto do Câncer e Transplante de Curitiba ( Site 0300) — Curitiba
• Liga Norte Riograndense Contra o Câncer ( Site 0307) — Natal
• Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) — São José do Rio Preto

Чехия · 4 центра

• Masarykuv onkologicky ustav ( Site 0903) — Brno
• Fakultni nemocnice Ostrava ( Site 0904) — Ostrava
• Fakultni nemocnice Hradec Kralove ( Site 0902) — Hradec Králové
• Fakultni nemocnice v Motole ( Site 0900) — Prague

Израиль · 4 центра

• Rambam Health Care Campus ( Site 1600) — Haifa
• Meir Medical Center. ( Site 1603) — Kfar Saba
• Rabin Medical Center ( Site 1602) — Petah Tikva
• Sheba Medical Center ( Site 1601) — Ramat Gan

Греция · 3 центра

• Alexandra General Hospital of Athens ( Site 1400) — Athens
• ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401) — Athens
• Metropolitan Hospital ( Site 1402) — Athens

Нидерланды · 3 центра

• Maastricht UMC+ ( Site 1901) — Maastricht
• Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900) — Amsterdam
• Haga Ziekenhuis locatie Leyweg ( Site 1906) — The Hague

South Korea · 3 центра

• Severance Hospital, Yonsei University Health System ( Site 2903) — Seoul
• Asan Medical Center ( Site 2901) — Seoul
• Samsung Medical Center ( Site 2902) — Seoul

США · 2 центра

• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102) — Marietta
• The West Clinic, P.C. ( Site 0115) — Germantown

Дания · 2 центра

• Herlev Hospital ( Site 1002) — Herlev
• Aarhus Universitetshospital, Skejby ( Site 1001) — Aarhus

Австралия · 1 центр

• Macquarie University ( Site 2700) — Macquarie University

Германия · 1 центр

• Universitätsklinikum Jena ( Site 1313) — Jena

Великобритания · 1 центр

• The Christie Hospital NHS Foundation Trust ( Site 2601) — Withington

Идентификаторы

NCT: NCT07489495 · 6482-034 · U1111-1311-4692 · 2024-516993-31-00 · LITESPARK-034 · MK-6482-034 · LS-034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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