A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
NCT ID: NCT06385080
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
287 participants
INTERVENTIONAL
2024-04-22
2032-12-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous (IV) injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).
Amivantamab
Amivantamab will be administered subcutaneously.
Pembrolizumab
Pembrolizumab will be administered intravenously.
Cohort 5: Pembrolizumab + Amivantamab + Carboplatin (Dose Expansion)
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards in addition to intravenous injection of pembrolizumab 200 mg on Day 1 of each cycle, and carboplatin (area under the concentration-time curve \[AUC\] 5 milligram per milliliter \[mg/ml\]\*min) q3w on Day 1 of Cycles 1-6.
Amivantamab
Amivantamab will be administered subcutaneously.
Pembrolizumab
Pembrolizumab will be administered intravenously.
Carboplatin
Carboplatin will be administered intravenously.
Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.
Amivantamab
Amivantamab will be administered subcutaneously.
Paclitaxel
Paclitaxel will be administered intravenously.
Cohort 3B (Dose Expansion): Amivantamab + Paclitaxel
Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.
Amivantamab
Amivantamab will be administered subcutaneously.
Paclitaxel
Paclitaxel will be administered intravenously.
Cohort 4: Amivantamab Monotherapy
Participants will receive subcutaneous injection of amivantamab monotherapy 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards.
Amivantamab
Amivantamab will be administered subcutaneously.
Cohort 1: Amivantamab Monotherapy (Dose Expansion)
Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \>=80 kilograms \[kg\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.
Amivantamab
Amivantamab will be administered subcutaneously.
Cohort 6: Amivantamab + Pembrolizumab
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle) (Neoadjuvant Phase). In the adjuvant phase, pembrolizumab IV (200 mg) will be administered q3w from Adjuvant Cycle 1 Day 1 to Adjuvant Cycle 15 Day 1 and amivantamab SC 2,400 mg (3,360 mg for \>80 kg) will be administered q3w from Adjuvant Cycle 4 Day 1 to Adjuvant Cycle 15 Day 1.
Amivantamab
Amivantamab will be administered subcutaneously.
Pembrolizumab
Pembrolizumab will be administered intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amivantamab
Amivantamab will be administered subcutaneously.
Pembrolizumab
Pembrolizumab will be administered intravenously.
Paclitaxel
Paclitaxel will be administered intravenously.
Carboplatin
Carboplatin will be administered intravenously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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 District, , Taiwan
Addenbrooke's Hospital
Cambridge, , United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, , 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
Royal Marsden Hospital
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
61186372HNC2002
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508418-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
61186372HNC2002
Identifier Type: -
Identifier Source: org_study_id