A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

Официальное название

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Обзор

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Вмешательства

• Биопрепарат Amivantamab
  Amivantamab will be administered.
• Биопрепарат Pembrolizumab
  Pembrolizumab will be administered.
• Препарат Carboplatin
  Carboplatin will be administered.
• Препарат 5-Flurouracil
  5-Flurouracil will be administered for over 4-day infusion period.
• Препарат Cisplatin
  Cisplatin will be administered.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to approximately 3 years 7 months]
• Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 3 years 7 months]

Вторичные конечные точки (12)

• Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR [Срок оценки: Up to approximately 3 years 7 months]
• Duration of Response (DOR) As Assessed by BICR [Срок оценки: Up to approximately 3 years 7 months]
• ORR as Assessed by Investigator [Срок оценки: Up to approximately 3 years 7 months]
• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 3 years 7 months]
• Number of Participants with Laboratory Abnormalities [Срок оценки: Up to approximately 3 years 7 months]
• Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score [Срок оценки: Baseline, up to approximately 3 years 7 months]
• Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score [Срок оценки: Baseline, up to approximately 3 years 7 months]
• Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30 [Срок оценки: Baseline, up to approximately 3 years 7 months]
• Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30 [Срок оценки: Baseline, up to approximately 3 years 7 months]
• Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores [Срок оценки: Up to approximately 3 years 7 months]
• Serum Concentration of Amivantamab [Срок оценки: Up to approximately 3 years 7 months]
• Number of Participants with Serum Anti-Amivantamab Antibodies [Срок оценки: Up to approximately 3 years 7 months]

Критерии участия

Критерии включения

• Be more than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)
• Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
• Be treatment-naive for systemic therapy in the R/M setting
• Have an ECOG performance status of 0 or 1
• Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1

Критерии исключения

• Have an uncontrolled illness
• Have untreated brain metastases or history of known presence of leptomeningeal disease
• Have a history of clinically significant cardiovascular disease
• Inadequate organ or bone marrow function
• Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase

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

США · 46 центров

• Ironwood Cancer and Research Center — Chandler
• University of Arizona Cancer Center — Tucson
• Providence St Jude Medical Center — Fullerton
• Scripps Health — La Jolla
• Valkyrie Clinical Trials — Los Angeles
• University of California, Los Angeles UCLA — Los Angeles
• Valkyrie Clinical Trials Murrieta — Murrieta
• University Of California - Davis — Sacramento
• … и ещё 38 центров

Китай · 25 центров

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Tongren Hospital Outpatient Bldg — Пекин
• Beijing Cancer Hospital — Пекин
• The Affiliated Hospital of Bengbu Medical College — Bengbu
• The second Xiangya Hospital of Central South University — Чанша
• Hunan Cancer hospital — Чанша
• Sichuan Cancer Hospital — Чэнду
• West China Hospital Sichuan University — Чэнду
• … и ещё 17 центров

Великобритания · 11 центров

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Германия · 9 центров

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Франция · 8 центров

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Япония · 8 центров

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Испания · 8 центров

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Италия · 7 центров

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Тайвань · 7 центров

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Бразилия · 6 центров

• Fundacao Doutor Amaral Carvalho — Jaú
• Liga Norte Riograndense Contra O Cancer — Natal
• Irmandade da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
• Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pes — São José do Rio Preto
• Hospital Alemao Oswaldo Cruz — São Paulo
• Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia — Vitória

Чехия · 6 центров

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Венгрия · 6 центров

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Индия · 6 центров

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Мексика · 6 центров

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Польша · 6 центров

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Румыния · 6 центров

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Австралия · 5 центров

• Monash Medical Centre — Clayton
• Liverpool Hospital — Liverpool
• Peter MacCallum Cancer Centre — Melbourne
• St John of God Hospital Murdoch — Murdoch
• GenesisCare — St Leonards

Австрия · 5 центров

• Tirol Kliniken MedUni Innsbruck — Innsbruck
• Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart — Oberwart
• Universitaetsklinikum Salzburg Landeskrankenhaus — Salzburg
• University Hospital St. Poelten — Sankt Pölten
• Medical University Vienna MUV — Vienna

Бельгия · 5 центров

• UZ Antwerpen — Edegem
• Chu Helora Hospital La Louviere Site Jolimont — Haine-Saint-Paul
• Universitair Ziekenhuis Leuven — Leuven
• Vitaz — Sint-Niklaas
• Institut Roi Albert II — Woluwe-Saint-Lambert

Португалия · 5 центров

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South Korea · 4 центра

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Нидерланды · 3 центра

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Идентификаторы

NCT: NCT07276399 · 61186372HNC3001 · 61186372HNC3001 · 2025-521917-24-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗