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), Paclitaxel (drug), Carboplatin (drug)
- How long the study runs
- Study runs about 111 months (dates as stated)
- About the drug or intervention
- Amivantamab — biological: Amivantamab will be administered subcutaneously. · Pembrolizumab — biological: Pembrolizumab will be administered intravenously. · Paclitaxel — drug: Paclitaxel will be administered intravenously. · Carboplatin — drug: Carboplatin will be administered intravenously.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 287
- Started
- 2024-04-22
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for squamous cell carcinoma of head and neck
- • Phase1/Phase2 - 287 participants
- • The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with squamous cell carcinoma of head and neck
Where?
- • Cambridge - Addenbrooke's Hospital
- • Guildford - The Royal Surrey County Hospital NHS Foundation Trust
- • London - Royal Marsden Hospital (Sutton)
- • London - Royal Marsden Hospital
- • +3 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 determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
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
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ results of p16 status, per local testing)
- ✓ measurable disease according to RECIST version 1
What the study is looking for
- ✓Have an activity scale (ECOG) performance status of 0 to 1
- ✓Participants should have: a) red blood cell level \>=9 grams per deciliter (g/dL); b) Neutrophils \>=1.5 x 10\^3/mcg; c)...
Who cannot take part
- ✗Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively...
- ✗Participant with a history of clinically significant cardiovascular disease
- ✗Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment
See the full criteria
Where Is This Study? (7 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford GU2 7XX, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Royal Marsden Hospital
London SW3 6JJ, United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London W12 0HS, United Kingdom
University College London Hospitals
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie Nhs Foundation Trust
Manchester M20 4BX, United Kingdom
How to Get in Touch
Study Contact
Sponsor contactCONTACT
