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Looking for participantsPhase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT07276399

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Amivantamab (biological), Pembrolizumab (biological), Carboplatin (drug), 5-Flurouracil (drug)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
Amivantamab — biological: Amivantamab will be administered. · Pembrolizumab — biological: Pembrolizumab will be administered. · Carboplatin — drug: Carboplatin will be administered. · 5-Flurouracil — drug: 5-Flurouracil will be administered for over 4-day infusion period. · Cisplatin — drug: Cisplatin will be administered.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
500
Started
2025-12-03
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for squamous cell carcinoma of head and neck
  • • Phase3 - 500 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with squamous cell carcinoma of head and neck

Where?

  • • Cambridge - Addenbrooke's Hospital
  • • Cottingham - Castle Hill Hospital
  • • Edinburgh - Western General Hospital
  • • Greater London - Guy's and St Thomas' NHS Foundation Trust
  • • +7 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

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 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.

Squamous Cell Carcinoma of Head and Neck

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

must be negative

Treatment history

Treatments you must have had:

  • ✓ documented local testing results per local regulations

What the study is looking for

  • ✓Be more than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study...
  • ✓Be treatment-naive for treatment that goes through your whole body in the R/M setting
  • ✓Have an Fit enough for normal activity (ECOG 0) or 1
  • ✓Have cancer that can be measured on scans 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
  • ✗Inadequate organ or bone marrow function
  • ✗Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab,...
See the full 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: * 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

Where Is This Study? (11 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Castle Hill Hospital

Cottingham HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Guy's and St Thomas' NHS Foundation Trust

Greater London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Royal Surrey County Hospital NHS Trust

Guildford GU2 7XX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting

Royal Marsden Hospital Chelsea

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Clatterbridge Cancer Centre

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Mount Vernon Cancer Centre

Northwood HA6 2RN, United Kingdom

Recruiting

Nottingham City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

The Royal Marsden NHS Trust Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09