Actively Recruiting
A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
287
Participants Needed
55
Research Sites
453 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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...
- Have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) considered incurable by local therapies (Cohorts 1 to 5) or locally advanced HNSCC considered curable by surgery (Cohort 6)
- For Cohorts 1, 2, 3A, and 3B: Tumor in oropharynx, oral cavity, hypopharynx, or larynx; known p16 status must be negative; participants with oropharyngeal tumors must have p16 status results
- For Cohort 4: Primary tumor in oropharynx; tumor must be HPV-positive confirmed by p16 or high-risk HPV ISH; PD-L1 status results if available
- For Cohort 5: Tumor in oropharynx, oral cavity, hypopharynx, or larynx; HPV status must be known for oropharyngeal tumors; PD-L1 status if available
- For Cohort 6: Tumor in oropharynx, oral cavity, hypopharynx, or larynx; known p16 status must be negative; participants with oropharyngeal tumors must have p16 status results
- Participants must provide PD-L1 status results if available
- Participants must have Stage III or IVa disease (Cohort 6) and resectable disease
- Measurable disease according to RECIST 1.1 for Cohorts 1, 2, 3B, 4, and 5; evaluable disease for Cohorts 3A and 6
- Toxicities from prior anticancer therapies resolved to baseline or Grade 1 or less (with exceptions) before first study treatment dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and bone marrow function with hemoglobin ≥9 g/dL, neutrophils ≥1.5 x 10^3/mcg, platelets ≥100 x 10^3/mcg, and no recent transfusions or growth factor use
You will not qualify if you...
- Uncontrolled illness including current or history of non-infectious interstitial lung disease, pneumonitis, or pulmonary fibrosis, or suspected cases not ruled out by imaging
- Untreated brain metastases, leptomeningeal disease, or spinal cord compression not treated definitively with surgery or radiation
- History of significant cardiovascular disease
- Received chemotherapy, targeted therapy, immunotherapy, or investigational anticancer agents within 2 weeks or 4 half-lives (maximum 28 days) before study treatment
- Received radiotherapy for palliative care within 7 days before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 55 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
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201 2013
Actively Recruiting
8
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
10
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
13
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
14
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
15
Beijing Cancer Hospital of Peking University
Beijing, China, 100142
Actively Recruiting
16
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, China, 610041
Actively Recruiting
17
Linyi Cancer Hospital
Linyi, China, 276002
Actively Recruiting
18
Fudan Cancer Hospital
Shanghai, China, 200032
Actively Recruiting
19
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
20
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
21
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
22
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
23
CHU Nantes
Nantes, France, 44000
Actively Recruiting
24
Institut Curie
Paris, France, 75248
Actively Recruiting
25
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
26
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
27
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Completed
28
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, Germany, 70174
Actively Recruiting
29
Aichi Cancer Center
Nagoya, Japan, 464-8681
Actively Recruiting
30
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Actively Recruiting
31
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
32
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
33
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 214
Actively Recruiting
34
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice, Poland, 44-102
Actively Recruiting
35
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02 781
Actively Recruiting
36
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
37
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
38
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
39
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
40
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
41
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, Spain, 08908
Actively Recruiting
42
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
43
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
44
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
45
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
46
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
47
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
48
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33382
Actively Recruiting
49
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
50
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
51
Royal Marsden Hospital (Sutton)
London, United Kingdom, SM2 5PT
Actively Recruiting
52
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
53
Imperial College London and Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
Actively Recruiting
54
University College London Hospitals
London, United Kingdom, W1T 7HA
Actively Recruiting
55
The Christie Nhs Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Study Contact
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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