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RecruitingLast updated: 22 January 2026

OrigAMI-5: Comparing treatment combinations (including targeted therapy, immunotherapy and chemotherapy) for people with refractory, metastatic head and neck squamous cell carcinoma who have not had prior treatment for their advanced cancerA 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 purpose

Medical clipboardCancer treatment

Tumor type

Head and Neck Cancers Head and Neck

Age

People18+

Trial acronym

OrigAMI-5

Clinical summary

Summary

Head and neck squamous cell carcinoma (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 refractory/metastatic (R/M) setting.

The study will be comparing the anti-cancer activity of two treatment combinations: amivantamab targeted therapy plus pembrolizumab immunotherapy and carboplatin chemotherapy versus pembrolizumab immunotherapy, 5-FU and platinum chemotherapy.

Eligible participants will be randomly allocated to one of two treatment arms:

  • Experimental: Pembrolizumab, amivantamab and carboplatin.
  • Active Comprator: Pembrolizumab, 5-FU and either carboplatin or cisplatin.

 

Conditions

This trial is treating people with refractory, metastatic head and neck squamous cell carcinoma who have not had prior treatment for their cancer in the r/m setting

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07276399 *
  • 2025-521917-24-00 *
  • 61186372HNC3001; 61186372HNC3001

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

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

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