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NCT06385080From ClinicalTrials.govRecruiting

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

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma

  • Squamous Cell Carcinoma of Head and Neck

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
287
Started
22 April 2024
Main results due
27 December 2032
Study sites
56
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(56)

  • University of California at San Diego Moores Cancer Center

    La Jolla, California, United States

    Completed

  • University of Colorado Denver Anschultz Medical Campus

    Aurora, Colorado, United States

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, United States

    Recruiting

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, United States

    Recruiting

  • University of Maryland School of Medicine

    Baltimore, Maryland, United States

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, United States

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, United States

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, United States

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, United States

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, United States

    Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, United States

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, United States

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, United States

    Recruiting

  • Beijing Cancer Hospital of Peking University

    Beijing, China

    Completed

  • West China School of Medicine/West China Hospital, Sichuan University

    Cheng Du Shi, China

    Recruiting

  • Linyi Cancer Hospital

    Linyi, China

    Completed

  • Fudan Cancer Hospital

    Shanghai, China

    Recruiting

  • Shanghai East Hospital

    Shanghai, China

    Recruiting

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, China

    Recruiting

  • Institut Sainte Catherine

    Avignon, France

    Recruiting

  • Centre Oscar Lambret

    Lille, France

    Recruiting

  • CHU Nantes

    Nantes, France

    Recruiting

  • Institut Curie

    Paris, France

    Recruiting

  • Gustave Roussy

    Villejuif, France

    Recruiting

  • Universitaetsklinikum Essen

    Essen, Germany

    Recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, Germany

    Completed

  • Klinikum der Landeshauptstadt Stuttgart

    Stuttgart, Germany

    Recruiting

  • Aichi Cancer Center

    Nagoya, Japan

    Recruiting

  • Tokyo Medical University Hospital

    Tokyo, Japan

    Recruiting

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, Malaysia

    Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia

    Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

    Recruiting

  • Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

    Gliwice, Poland

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, Poland

    Recruiting

  • Seoul National University Hospital

    Seoul, South Korea

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Recruiting

  • Asan Medical Center

    Seoul, South Korea

    Recruiting

  • Samsung Medical Center

    Seoul, South Korea

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, Spain

    Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, Spain

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spain

    Recruiting

  • Changhua Christian Hospital

    Changhua, Taiwan

    Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

    Recruiting

  • National Taiwan University Hospital

    Taipei, Taiwan

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, Taiwan

    Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, United Kingdom

    Recruiting

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford, United Kingdom

    Recruiting

  • Royal Marsden Hospital (Sutton)

    London, United Kingdom

    Recruiting

  • Royal Marsden Hospital

    London, United Kingdom

    Recruiting

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, United Kingdom

    Completed

  • University College London Hospitals

    London, United Kingdom

    Recruiting

  • The Christie Nhs Foundation Trust

    Manchester, United Kingdom

    Recruiting

Showing 56 of 56 sites. 51 of the 56 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06385080. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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