A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Официальное название

A Phase 2 Open-Label Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Pembrolizumab as First-Line Treatment in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Обзор

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide with an annual incidence of approximately 700,000 cases. This study aims to evaluate the change in disease activity and optimal dose, and optimal dose of telisotuzumab adizutecan in combination with pembrolizumab as first-line treatment in participants with recurrent or metastatic head and neck squamous cell carcinoma. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of recurrent or metastatic HNSCC. Participants are placed into 3 treatment groups called treatment arms. Each group receives a different treatment. Adult participants diagnosed with recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease and whose tumors express c-Met protein will be enrolled. Approximately 180 participants will be enrolled in the study at sites worldwide. Participants will receive intravenous doses of telisotuzumab adizutecan with intravenous pembrolizumab, or standard of care (SOC) chemotherapy with pembrolizumab. Participants will receive treatment as part of a 38 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits every 3 weeks during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат Telisotuzumab Adizutecan
  Intravenous (IV)
• Препарат Pembrolizumab
  IV
• Препарат Carboplatin
  IV
• Препарат Cisplatin
  IV
• Препарат Fluorouracil
  IV

Первичные конечные точки

• Number of Participants with Adverse Events (AE)s [Срок оценки: Up to Approximately 38 Months]
• Objective Response (OR) Rate Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• Progression-Free Survival (PFS) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]

Вторичные конечные точки (7)

• Duration of Response (DoR) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• Disease Control (DC) Based on Blinded Independent Central Review Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• OR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• PFS Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• DoR Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• DC Rate Based on Investigator Assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 [Срок оценки: Up to Approximately 38 Months]
• Overall Survival (OS) [Срок оценки: Up to Approximately 38 Months]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed diagnosis of recurrent or metastatic head and neck squamous cell carcinoma that is considered incurable by local therapies.
• Eastern cooperative oncology group (ECOG) performance status must be <= 1.
• Must have c-Met protein expression by central c-Met immunohistochemistry (IHC) staining at any intensity in >= 25% tumor cells.
• Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
• Must have had no prior systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Критерии исключения

• Have history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis on screening chest computed tomography (CT) scan.
• Have any major, life-threatening conditions.
• Life expectancy should be at least 3 months.

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 · 6 центров

• University of Arkansas for Medical Sciences /ID# 283444 — Little Rock
• Winship Cancer Institute of Emory University /ID# 282003 — Atlanta
• University of Chicago Medical Center /ID# 281748 — Chicago
• OU Health - Stephenson Cancer Center /ID# 282905 — Oklahoma City
• UT Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center /ID# 283638 — Dallas
• University of Virginia /ID# 281773 — Charlottesville

Китай · 5 центров

• Anhui Cancer Hospital /ID# 282354 — Хэфэй
• People's Hospital of Henan Province /ID# 282036 — Чжэнчжоу
• Hunan Province Cancer Hospital /ID# 282346 — Чанша
• The First Affiliated Hospital of Xi'an Jiaotong University /ID# 282115 — Сиань
• Fudan University Shanghai Cancer Center /ID# 282374 — Шанхай

Португалия · 5 центров

• Hospital da Luz /ID# 282666 — Lisbon
• Unidade Local de Saude de Loures-Odivelas /ID# 281306 — Loures
• Unidade Local de Saude de Almada-Seixal, EPE /ID# 281288 — Almada
• Unidade Local de Saude de Santa Maria /ID# 281281 — Lisbon
• Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 281282 — Porto

Япония · 3 центра

• Aichi Cancer Center /ID# 282273 — Nagoya
• Yokohama City University Hospital /ID# 282274 — Yokohama
• Osaka International Cancer Institute /ID# 282269 — Osaka

Испания · 1 центр

• Hospital Universitario de Salamanca /ID# 282672 — Salamanca

Идентификаторы

NCT: NCT07744126 · M26-120 · 2025-524179-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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