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Clinical Trials List

Protocol Number61186372HNC3001
NCT Number(ClinicalTrials.gov Identfier)NCT07276399
Active

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

    2026/04/08

Investigators and Locations

Principal Investigator Hui-Ching Wang Division of Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 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 Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Squamous Cell Carcinoma of Head and Neck

Objectives

The primary objective is to compare the antitumor activity (overall survival [OS] and overall response rate [ORR]) of amivantamab SC plus pembrolizumab and carboplatin compared with pembrolizumab, 5-FU, and platinum (carboplatin or cisplatin) in previously untreated R/M HNSCC participants. Secondary objectives will be to further evaluate safety and other efficacy endpoints, as well as patient-reported outcomes (PROs) and pharmacokinetics (PK).

Test Drug

Subcutaneous injection
Injection
Injection
Injection
Injection

Active Ingredient

amivantamab
Pembrolizumab
FLUOROURACIL
CARBOPLATIN
CISPLATIN

Dosage Form

220
270
270
270
270

Dosage

NA
25 mg/mL
50 mg/mL
10 mg/mL
1 mg/mL

Endpoints

1. Overall survival [OS]

2. Objective response rate [ORR] assessed by a blinded central independent review committee (BICR) using the Rec.1 version of the Solid Tumor Response Assessment Criteria (RECIST 1.1).

Inclution Criteria

Inclusion 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

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

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