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Contact Information:

Study Contact 844-434-4210
Participate-In-This-Study1@its.jnj.com


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Be Part of Research - Trial Details - A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Recruiting

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Squamous Cell Carcinoma of Head and Neck


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2024 Dec 2027

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Amivantamab will be administered subcutaneously.

Intervention Arm Group : Cohort 1: Amivantamab Monotherapy (Dose Expansion);Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in);Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel;Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel;Cohort 4: Amivantamab Monotherapy;Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion);Cohort 6: Amivantamab + Pembrolizumab;

Intervention Type : BIOLOGICAL
Intervention Description : Pembrolizumab will be administered intravenously.

Intervention Arm Group : Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in);Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion);Cohort 6: Amivantamab + Pembrolizumab;

Intervention Type : DRUG
Intervention Description : Paclitaxel will be administered intravenously.

Intervention Arm Group : Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel;Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel;

Intervention Type : DRUG
Intervention Description : Carboplatin will be administered intravenously.

Intervention Arm Group : Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Marsden Hospital
    London
    SW3 6JJ
  • Imperial College London and Imperial College Healthcare NHS Trust
    London
    W12 0HS
  • University College London Hospitals
    London
    W1T 7HA
  • The Royal Surrey County Hospital NHS Foundation Trust
    Guildford
    GU2 7XX
  • Royal Marsden Hospital (Sutton)
    London
    SM2 5PT
  • Addenbrooke's Hospital
    Cambridge
    CB2 0QQ
  • The Christie Nhs Foundation Trust
    Manchester
    M20 4BX


The study is sponsored by Janssen Research & Development, LLC




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Read full details for Trial ID: NCT06385080
Last updated 12 March 2026

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