Clinical Trials List
2025-10-01 - 2029-12-31
Recruiting7
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
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
-
Trial Applicant
Johnson & Johnson
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/08/13
Investigators and Locations
Co-Principal Investigator
- Jeng-Shiun Du Division of Hematology & Oncology
- Tsung-Jang Yeh Division of Hematology & Oncology
- 王閔宏 Division of Hematology & Oncology
- 謝子禹 Division of Hematology & Oncology
- 許瑞峰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王郁棻
- RUEY-LONG HONG
- 黃彥霖
- HUAI-CHENG HUANG
- 楊明翰 Division of Hematology & Oncology
- 廖斌志
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ching-Chan Lin
- Ming-Yu Lien Division of Hematology & Oncology
- 陳珈妤
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Jui Yen Division of Hematology & Oncology
- 劉奕廷
- 鍾秉軒 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
皮下注射劑
注射劑
注射劑
注射劑
Active Ingredient
amivantamab
Pembrolizumab
CARBOPLATIN
CISPLATIN
Dosage Form
220
270
270
270
Dosage
mg/vial
100 mg/vial
600 mg/vial
Endpoints
2. 2.由盲性中央獨立評估委員會 (BICR)使用固體腫瘤反應評估標準第1.1版（RECIST 1.1）評估的客觀反應率 [ORR]
Inclution Criteria
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
Exclusion Criteria
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
The Estimated Number of Participants
-
Taiwan
25 participants
-
Global
500 participants
