Futibatinib (TAS-120) in Patients With Advanced Biliary Tract Cancer

Официальное название

A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Обзор

To compare overall survival (OS) of patients in Futibatinib and Zimberelimab in Combination with Gemcitabine plus Cisplatin versus Durvalumab or Pembrolizumab in Combination with Gemcitabine plus Cisplatin for patients with first-line advanced biliary tract cancer

Вмешательства

• Препарат Futibatinib
  Futibatinib 20 mg will be administered orally once daily.
• Препарат Zimberelimab
  Zimberelimab 360 mg will be administered on Day 1 of each 3-week cycle (Q3W) by intravenous infusion.
• Препарат Durvalumab
  Durvalumab 1500 mg will be administered on Day 1 of Q3W by intravenous infusion.
• Препарат Pembrolizumab
  Pembrolizumab 200 mg will be administered on Day 1 of Q3W by intravenous infusion.
• Препарат Gemcitabine
  Gemcitabine 1000 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.
• Препарат Cisplatin
  Cisplatin 25 mg/m2 will be administered Days 1 and 8 of Q3W by intravenous infusion.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to approximately 45 months]

Вторичные конечные точки (5)

• Progression-Free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 using Blinded Independent Central Review (BICR) and Investigator assessment [Срок оценки: Up to approximately 45 months]
• 6-months PFS rate according to RECIST v1.1 using BICR and Investigator assessments [Срок оценки: Up to approximately 45 months]
• Objective response rate (ORR) according to RECIST v1.1 using BICR and Investigator assessments [Срок оценки: Up to approximately 45 months]
• Duration of response (DoR) according to RECIST v1.1 using BICR and Investigator assessments [Срок оценки: Up to approximately 45 months]
• Adverse events (AEs) [Срок оценки: Up to approximately 45 months]

Критерии участия

Критерии включения

• Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;
• Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);

• Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.
• Has radiographically measurable disease per RECIST v1.1.
• Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.
• Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Критерии исключения

• History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;
• History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;
• Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib
• Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

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

Открытое

Основная цель

Лечение

Центры проведения

Япония · 11 центров

• Research Site — Aichi
• National Hospital Organization Kyushu Cancer Center — Fukuoka
• Research Site — Fukuoka
• Research Site — Hokkaido
• Kanagawa Cancer Center — Kanagawa
• Research Site — Miyagi
• Research Site — Osaka
• Research Site — Tokyo
• … и ещё 3 центра

Австралия · 4 центра

• Research Site — Brisbane
• Research Site — Melbourne
• Research Site — Perth
• Research Site — Sydney

South Korea · 4 центра

• Research Site — Busan
• Research Site — Hwasun
• Research Site — Seongnam
• Research Site — Seoul

Таиланд · 2 центра

• Research Site — Bangkok
• Research Site — Chiang Mai

Идентификаторы

NCT: NCT07710885 · 10059040 · jRCT2071260018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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