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Clinical Trials List

Protocol Number61186372HNC3001
Active

2025-10-01 - 2029-12-31

Phase III

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-Naive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Johnson & Johnson

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiang-Fong Kao Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ching Yun Hsieh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林進清 Division of Radiation Therapy
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hui-Ching Wang
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Objectives

The primary objective of this study is to compare the antitumor activity of amivantamab in combination with pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (5-FU), and a platinum agent (carboplatin or cisplatin) in participants with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

Test Drug

Subcutaneous injection
Injection
Injection
Injection
Injection

Active Ingredient

amivantamab
Pembrolizumab
FLUOROURACIL
CARBOPLATIN
CISPLATIN

Dosage Form

220
270
270
270
270

Dosage

MG

Endpoints

1. Overall Survival (OS)

2. Objective Response Rate (ORR) as assessed by the Blinded Independent Central Review (BICR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Inclution Criteria

Age ≥ 18 years.

Histologically or cytologically confirmed recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is not amenable to curative local therapy.
a. Eligible primary tumor sites include the oral cavity, oropharynx, hypopharynx, or larynx.
b. Primary tumors of the nasopharynx (any histology) or unknown primary sites are not eligible.
c. Locally documented test results must be available per applicable regulatory requirements.
d. For participants with oropharyngeal primary tumors, HPV status must be determined by p16 immunohistochemistry, HPV DNA testing, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH tumor status must be negative.

No prior systemic therapy for recurrent or metastatic disease.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria

Presence of uncontrolled disease.


Untreated brain metastases or known history of leptomeningeal disease.


Clinically significant cardiovascular disease history.


Inadequate organ or bone marrow function.


Known hypersensitivity, allergy, contraindication, or intolerance to the excipients or components of any of the following drugs: amivantamab, pembrolizumab, carboplatin, cisplatin, 5-fluorouracil (5-FU), or hyaluronidase.

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    500 participants

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