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Looking for participantsPhase1/Phase2

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT06385080

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), 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).

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

Biomarkers mentioned

PD-L1must be negativeconfirmed by positiveeither positiveor negative

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
Inclusion Criteria: * Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease * Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1. * Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \[any grade\], Grade less than or equal to \[\<=\]2 peripheral neuropathy and Grade \<=2 hypothyroidism stable on hormone replacement) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test. Participants should have: a) Hemoglobin \>=9 grams per deciliter (g/dL); b) Neutrophils \>=1.5 x 10\^3/mcg; c) Platelets \>=100 x 10\^3/mcg Exclusion Criteria: * Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation * Participant with a history of clinically significant cardiovascular disease * Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days * Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment

Where Is This Study? (7 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

The Royal Surrey County Hospital NHS Foundation Trust

Guildford GU2 7XX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

Royal Marsden Hospital (Sutton)

London SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Imperial College London and Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

University College London Hospitals

London W1T 7HA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Christie Nhs Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

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