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Taking people in United StatesPhase 3

Amivantamab added to standard drugs for untreated advanced head and neck cancer

Tests amivantamab plus standard drugs in adults with untreated advanced head and neck cancer.

Key facts

Who runs it
Janssen Research & Development, LLC
Where
Ann Arbor, Atlanta, Baltimore, Boston, Chandler, Charlottesville, Chicago, Cincinnati, Columbus, Dallas, Detroit, Fairfax, Fort Myers, Fredericksburg, Fullerton, Hartford, Hershey, Houston, Knoxville, La Jolla, Lexington, Lincoln, Los Angeles, Macon, Miami, Mineola, Murrieta, Nashville, New Brunswick, New Haven, New York, O'Fallon, Orlando, Philadelphia, Portland, Sacramento, Salt Lake City, San Francisco, St Louis, St. Petersburg, Stanford, The Bronx, Tucson, Tyler, Waco, West Palm Beach, and Wilson, United StatesSee the 51 sitesAlso in 21 other countries, 155 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
600 people, planned
Started
3 Dec 2025
Expected to end
18 Jul 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Amivantamab
  • Pembrolizumab
  • Carboplatin
  • 5-Flurouracil
  • Cisplatin
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with head and neck squamous cell cancer that has come back or spread and cannot be cured by local treatment. They must not have had any drug treatment yet for this stage.

Age
18 years or older (or the legal age of adulthood where the study takes place, if higher).
Sex
All sexes can join.
Disease stage
Squamous cell cancer of the head and neck that has come back or spread, confirmed under the microscope, that local treatment cannot remove. The cancer must start in the mouth, oropharynx, hypopharynx or larynx. It must be measurable by scan (RECIST v.1.1). Activity level (ECOG) must be 0 or 1.
Earlier treatment
No earlier drug (systemic) treatment for the recurrent or metastatic cancer.
Biomarker or test result
For tumors starting in the oropharynx, HPV status must be known. Any known p16, HPV DNA or high-risk HPV test result must be negative.

Main reasons for not taking part

  • Cancer starting in the nasopharynx, or a primary tumor of unknown location
  • Uncontrolled illness
  • Untreated brain metastases or known leptomeningeal disease
  • Clinically significant heart or blood vessel disease
  • Not enough organ or bone marrow function

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have an uncontrolled illness
  • Have untreated brain metastases or history of known presence of leptomeningeal disease
  • Have a history of clinically significant cardiovascular disease
  • Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase
  • Inadequate organ or bone marrow function

Where in United States

Also in 21 other countries, 155 sites

  • Trinity Health St Joseph Mercy Ann ArborAnn Arbor, United StatesTaking people
  • Emory UniversityAtlanta, United StatesTaking people
  • University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
  • Dana-Farber Cancer InstituteBoston, United StatesTaking people
  • Ironwood Cancer and Research CenterChandler, United StatesTaking people
  • University of VirginiaCharlottesville, United StatesTaking people
  • Rush University Medical Center Rush University Cancer Center ChicagoChicago, United StatesTaking people
  • The University of Chicago Medical Center (UCMC)Chicago, United StatesTaking people
  • University of CincinnatiCincinnati, United StatesTaking people
  • Ohio State UniversityColumbus, United StatesTaking people
  • UT Southwestern Medical CenterDallas, United StatesTaking people
  • Karmanos Cancer InstituteDetroit, United StatesTaking people
  • Virginia Cancer SpecialistsFairfax, United StatesTaking people
  • Florida Cancer Specialists - SouthFort Myers, United StatesTaking people
  • Texas Oncology - San AntonioFredericksburg, United StatesTaking people
  • Providence St. Jude Medical CenterFullerton, United StatesTaking people
  • Hartford HospitalHartford, United StatesTaking people
  • Penn State Milton S. Hershey Medical CenterHershey, United StatesTaking people
  • MD Anderson Cancer CenterHouston, United StatesTaking people
  • Tennessee Cancer SpecialistsKnoxville, United StatesTaking people
  • Scripps HealthLa Jolla, United StatesTaking people
  • University of Kentucky Medical CenterLexington, United StatesTaking people
  • NHO Revive Research Institute, LLCLincoln, United StatesTaking people
  • University of California Los Angeles (UCLA).Los Angeles, United StatesTaking people
  • Valkyrie Clinical TrialsLos Angeles, United StatesTaking people
  • Central Georgia Cancer CareMacon, United StatesTaking people
  • University of Miami - Sylvester Comprehensive Cancer CenterMiami, United StatesTaking people
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, United StatesTaking people
  • Valkyrie Clinical Trials MurrietaMurrieta, United StatesTaking people
  • Vanderbilt University Medical CenterNashville, United StatesTaking people
  • Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
  • Yale Cancer CenterNew Haven, United StatesTaking people
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesTaking people
  • Cancer Care Specialists of Central IllinoisO'Fallon, United StatesTaking people
  • AdventHealth Medical Group Oncology and Hematology at OrlandoOrlando, United StatesTaking people
  • Fox Chase Cancer CenterPhiladelphia, United StatesTaking people
  • University of Pennsylvania - Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
  • Oregon Health and Science UniversityPortland, United StatesTaking people
  • University of California - DavisSacramento, United StatesTaking people
  • Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
  • UCSF Medical Center at Mission BaySan Francisco, United StatesTaking people
  • Washington University School of MedicineSt Louis, United StatesTaking people
  • Florida Cancer Specialists - North RegionSt. Petersburg, United StatesTaking people
  • Stanford University Medical CenterStanford, United StatesTaking people
  • Bronx Veterans Affairs Medical CenterThe Bronx, United StatesTaking people
  • Montefiore Medical CenterThe Bronx, United StatesTaking people
  • University of Arizona Cancer CenterTucson, United StatesTaking people
  • UT Health East Texas HOPE Cancer CenterTyler, United StatesTaking people
  • Texas Oncology - Central SouthWaco, United StatesTaking people
  • Florida Cancer Specialists - EastWest Palm Beach, United StatesTaking people
  • Carolina Cancer Research CenterWilson, United StatesTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm A: Pembrolizumab, Amivantamab, CarboplatinTreatment being tested

    Participants will receive pembrolizumab, amivantamab and carboplatin.

    Treatment: Amivantamab, Pembrolizumab, and Carboplatin

  • Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or CisplatinExisting treatment, for comparison

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

    Treatment: Pembrolizumab, Carboplatin, 5-Flurouracil, and Cisplatin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Amivantamab added to standard drugs for untreated advanced head and neck cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
3 November 2026