Amivantamab with Standard Care for Head and Neck Cancer

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

Recruiting Phase 3 Interventional Study
Squamous Cell Carcinoma of Head and Neck
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Who this trial is looking for

This trial is looking for adults with advanced head and neck cancer who have not received prior treatment. Participants will compare a combination of amivantamab and other standard medications against standard medications alone.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have advanced head and neck cancer that is not curable with local treatment.
  • I have not received systemic therapy for my cancer before.
  • I have a good performance status with no severe symptoms.
  • I have measurable disease according to specific criteria.
  • I have my tumor tested and know my HPV status.

You may not be able to join if

  • I have an uncontrolled illness.
  • I have untreated brain metastases.
  • I have a history of significant heart disease.
  • I have problems with my organs or bone marrow.
  • I am allergic to any of the medications being studied.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 tis…
Trial Locations
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Eligibility 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 th…
Contacts

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

CONTACT