Actively Recruiting
A Phase 1b/2, Open-label Study of Amivantamab Alone or with Other Treatments in Participants With Head and Neck Squamous Cell Carcinoma
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
287
Participants Needed
56
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and early effectiveness of amivantamab alone and combined with other treatments in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), as well as in those with locally advanced HNSCC who can undergo surgery. The study also seeks to confirm the recommended Phase 2 dose of amivantamab when given with paclitaxel and to assess amivantamab combined with pembrolizumab in the perioperative setting. Participants receive amivantamab via subcutaneous injection with varying doses depending on body weight, given weekly in the first cycle and every three weeks thereafter. Some groups also receive intravenous pembrolizumab, paclitaxel, or carboplatin, either alone or in combination with amivantamab. One cohort will have the amivantamab dose confirmed before continuing treatment. Another cohort will receive amivantamab and pembrolizumab before and after surgery in neoadjuvant and adjuvant phases. Participants will be closely monitored through assessments including tumor response and survival over approximately two years. Safety will be tracked by observing side effects and treatment-related toxicities. Blood samples will be taken to study drug levels and effects. Study visits will include physical exams, laboratory tests, imaging, and questionnaires to evaluate treatment impact and overall health status throughout the trial.
CONDITIONS
Brief Title
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma considered incurable by local therapies or locally advanced HNSCC considered curable by surgery
- Primary tumor located in oropharynx, oral cavity, hypopharynx, or larynx, with specific HPV and p16 status requirements depending on cohort
- Provide local testing results of PD-L1 status if available
- Measurable or evaluable disease according to RECIST version 1.1 depending on cohort
- Toxicities from prior anticancer therapies resolved to baseline or Grade 1 or less (except specified exceptions)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and bone marrow function without recent transfusions or growth factor use
- Hemoglobin ≥9 g/dL; neutrophils ≥1.5 x 10^3/mcg; platelets ≥100 x 10^3/mcg
You will not qualify if you...
- Uncontrolled illness including non-infectious interstitial lung disease, pneumonitis, or pulmonary fibrosis
- Untreated brain metastases, leptomeningeal disease, or spinal cord compression not treated definitively
- History of significant cardiovascular disease
- Received chemotherapy, targeted therapy, immunotherapy, or investigational anticancer agent within 2 weeks or 4 half-lives (maximum 28 days) before study treatment
- Received palliative radiotherapy within 7 days before study treatment start
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years and 2 months
Participants receive amivantamab alone or in combination with pembrolizumab, paclitaxel, and/or carboplatin depending on their assigned cohort. Treatments include subcutaneous injections of amivantamab weekly during the first cycle, then every 3 weeks thereafter, along with intravenous infusions of pembrolizumab, paclitaxel, and/or carboplatin according to the study schedule.
Weekly visits during Cycle 1 followed by visits every 3 weeks from Cycle 2 onwards
Duration - Up to 2 years and 2 months
Participants are monitored for safety and effectiveness after completion of treatment.
Visits every 3 months or as scheduled by the study team
Trial Site Locations
Total: 56 locations
1
University of California at San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Completed
2
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States, 60637
Actively Recruiting
5
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201 2013
Actively Recruiting
9
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
11
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
14
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
15
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
16
Beijing Cancer Hospital of Peking University
Beijing, China, 100142
Actively Recruiting
17
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, China, 610041
Actively Recruiting
18
Linyi Cancer Hospital
Linyi, China, 276002
Actively Recruiting
19
Fudan Cancer Hospital
Shanghai, China, 200032
Actively Recruiting
20
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
21
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
22
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
23
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
24
CHU Nantes
Nantes, France, 44000
Actively Recruiting
25
Institut Curie
Paris, France, 75248
Actively Recruiting
26
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
27
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
28
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Completed
29
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
30
Aichi Cancer Center
Nagoya, Japan, 464-8681
Actively Recruiting
31
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Actively Recruiting
32
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
33
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
34
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 214
Actively Recruiting
35
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice, Poland, 44-102
Actively Recruiting
36
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02 781
Actively Recruiting
37
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
38
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
39
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
40
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
41
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
42
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain, 08908
Actively Recruiting
43
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
44
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
45
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
46
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
47
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
48
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
49
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33382
Actively Recruiting
50
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
51
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
52
Royal Marsden Hospital (Sutton)
London, United Kingdom, SM2 5PT
Actively Recruiting
53
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
54
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
55
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
56
The Christie Nhs Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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