A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer (OrigAMI-5)

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 3

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Flurouracil; Biological: Pembrolizumab; Biological: Amivantamab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07276399

2025-521917-24-00 (Registry Identifier)

61186372HNC3001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Arm A: Pembrolizumab, Amivantamab, Carboplatin

Experimental group

Description:

Participants will receive pembrolizumab, amivantamab and carboplatin.

Treatment:

Biological: Pembrolizumab

Biological: Amivantamab

Drug: Carboplatin

Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin

Active Comparator group

Description:

Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).

Treatment:

Biological: Pembrolizumab

Drug: 5-Flurouracil

Drug: Cisplatin

Drug: Carboplatin