A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Официальное название

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Обзор

This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).

Вмешательства

• Препарат JNJ-90301900
  JNJ-90301900 will administered via intratumoral and/or intranodal injection.
• Препарат Cisplatin
  Cisplatin will be administered intravenously.
• Лучевая терапия Intensity Modulated Radiation Therapy (IMRT)
  IMRT radiation therapy will be administered.
• Препарат Carboplatin
  Carboplatin will be administered intravenously.
• Препарат Paclitaxel
  Paclitaxel will be administered intravenously.

Первичные конечные точки

• Number of Participants with Adverse Events (AEs) by Severity [Срок оценки: Up to approximately 2 years 14 weeks]

Вторичные конечные точки (9)

• Complete Response (CR) Rate [Срок оценки: Up to approximately 2 years 14 weeks]
• Objective Response Rate (ORR) According to RECIST v.1.1 [Срок оценки: Up to approximately 2 years 14 weeks]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years 14 weeks]
• Injected Tumor Response Rate [Срок оценки: Up to approximately 2 years 14 weeks]
• Time to Locoregional Failure (LRF) [Срок оценки: Up to approximately 2 years 14 weeks]
• Time to Distant Failure (DF) [Срок оценки: Up to approximately 2 years 14 weeks]
• Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years 14 weeks]
• Number of Participants with Post-Radiation Neck Dissection (PRND) [Срок оценки: Up to approximately 2 years 14 weeks]
• Number of Participants with Post-Radiation Primary Surgery [Срок оценки: Up to approximately 2 years 14 weeks]

Критерии участия

Критерии включения

• Pathologically (histologically or cytologically) proven diagnosis of HNSCC of the oral cavity, oropharynx (p16 negative), hypopharynx, or supraglottic larynx
• Stage III, IVA or IVB according to the 8th Edition of the American Joint Committee on Cancer (AJCC) guidelines
• A candidate for definitive concurrent chemoradiation therapy treatment as determined by investigator and per local guidelines
• Participants must have at least 1 target lesion (primary tumor or involved lymph node) per RECIST v.1.1
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1

Критерии исключения

• Primary tumor originating in the nasopharynx, paranasal sinuses, salivary glands, thyroid gland, parathyroid gland, skin, or unknown primary site
• Non-squamous histology
• Stages 0, I, II, and IVC HNSCC, loco-regionally recurrent HNSCC, or synchronous second primary HNSCC (within 2 months)
• Ineligible to receive platinum-based chemotherapy
• Suspected or known allergies, hypersensitivity, or intolerance to JNJ-90301900 or its excipients

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• University of Alabama at Birmingham — Birmingham
• City of Hope — Duarte
• University of California at San Diego Moores Cancer Center — La Jolla
• Mayo Clinic — Jacksonville
• Moffit Cancer center — Tampa
• Emory University — Atlanta
• Boston Medical Center — Boston
• Montefiore Medical Center — The Bronx
• … и ещё 2 центра

Франция · 5 центров

• Hopital De La Cavale Blanche — Brest
• Centre Oscar Lambret — Lille
• Hopital La Timone — Marseille
• Centre Henri Becquerel — Rouen
• Gustave Roussy — Villejuif

Япония · 4 центра

• Hiroshima University Hospital — Hiroshima
• Aichi Cancer Center — Nagoya
• Shizuoka Cancer Center — Shizuoka
• Tokyo Medical University Hospital — Tokyo

Идентификаторы

NCT: NCT07219212 · 90301900HNC1001 · 2025-522914-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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