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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (11 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Castle Hill Hospital
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Greater London SE1 9RT, United Kingdom
Royal Surrey County Hospital NHS Trust
Guildford GU2 7XX, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Marsden Hospital Chelsea
London SW3 6JJ, United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Mount Vernon Cancer Centre
Northwood HA6 2RN, United Kingdom
Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
