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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