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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06385080

Registry updated: 2026-09-25
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Description

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).

Interventions

  • 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.

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

Conditions

Squamous Cell Carcinoma of Head and Neck

Locations

  • University of California at San Diego Moores Cancer Center — La Jolla, California, United States
  • University of Colorado Denver Anschultz Medical Campus — Aurora, Colorado, United States
  • Yale Cancer Center — New Haven, Connecticut, United States
  • The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
  • University of Maryland School of Medicine — Baltimore, Maryland, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • Karmanos Cancer Institute — Detroit, Michigan, United States
  • Washington University School Of Medicine — St Louis, Missouri, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
  • University of Virginia — Charlottesville, Virginia, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
  • Beijing Cancer Hospital of Peking University — Beijing, China
  • West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi, China
  • Linyi Cancer Hospital — Linyi, China
  • Fudan Cancer Hospital — Shanghai, China
  • Shanghai East Hospital — Shanghai, China
  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology — Wuhan, China
  • Institut Sainte Catherine — Avignon, France
  • Centre Oscar Lambret — Lille, France
  • CHU Nantes — Nantes, France
  • Institut Curie — Paris, France
  • Gustave Roussy — Villejuif, France
  • Universitaetsklinikum Essen — Essen, Germany
  • Universitaetsklinikum Leipzig — Leipzig, Germany
  • Klinikum der Landeshauptstadt Stuttgart — Stuttgart, Germany
  • Aichi Cancer Center — Nagoya, Japan
  • Tokyo Medical University Hospital — Tokyo, Japan
  • Pantai Hospital Kuala Lumpur — Kuala Lumpur, Malaysia
  • University Malaya Medical Centre — Kuala Lumpur, Malaysia
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
  • Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach — Gliwice, Poland
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw, Poland
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital Yonsei University Health System — Seoul, South Korea
  • Asan Medical Center — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Hosp Univ Vall D Hebron — Barcelona, Spain
  • Inst. Cat. Doncologia-H Duran I Reynals — Barcelona, Spain
  • Hosp. Univ. Ramon Y Cajal — Madrid, Spain
  • Hosp. Univ. 12 de Octubre — Madrid, Spain
  • Changhua Christian Hospital — Changhua, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
  • Addenbrooke's Hospital — Cambridge, United Kingdom
  • The Royal Surrey County Hospital NHS Foundation Trust — Guildford, United Kingdom
  • Royal Marsden Hospital (Sutton) — London, United Kingdom
  • Royal Marsden Hospital — London, United Kingdom
  • Imperial College London and Imperial College Healthcare NHS Trust — London, United Kingdom
  • University College London Hospitals — London, United Kingdom
  • The Christie Nhs Foundation Trust — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record