Actively Recruiting
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab Compared to Standard Platinum, Pembrolizumab, and 5-FU in Treatment-Naive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
500
Participants Needed
186
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-tumor activity of adding amivantamab to pembrolizumab and carboplatin compared to pembrolizumab combined with 5-fluorouracil and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have not received prior systemic treatment in this setting. HNSCC is a cancer affecting areas such as the mouth and throat. This phase 3, randomized, open-label study aims to better understand treatment options for this condition. Participants are assigned randomly to one of two treatment groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other group receives pembrolizumab, 5-fluorouracil (administered via a 4-day infusion), and either carboplatin or cisplatin. The treatments are given as part of standard care agents, and the study compares these combinations to assess their effects and safety over time. Throughout the study, participants will be monitored for overall survival and tumor response using established criteria over approximately three years and seven months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires focusing on symptoms and functioning, and safety evaluations such as adverse event tracking and laboratory testing. Blood samples will also be collected to measure amivantamab concentration and antibodies. The study involves multiple visits and evaluations to thoroughly assess the treatments' impact and participant well-being.
CONDITIONS
Brief Title
A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older (or legal age of majority)
- Have confirmed recurrent or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
- Primary tumor located in oral cavity, oropharynx, hypopharynx, or larynx
- No primary tumor in nasopharynx or unknown location
- Known HPV status negative for participants with oropharynx tumors
- Not previously treated with systemic therapy in the recurrent/metastatic setting
- ECOG performance status of 0 or 1
- Have measurable disease per RECIST version 1.1
You will not qualify if you...
- Have uncontrolled illness
- Have untreated brain metastases or known leptomeningeal disease
- History of clinically significant cardiovascular disease
- Inadequate organ or bone marrow function
- Known allergies or intolerance to study drugs or their excipients including Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU, and Hyaluronidase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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 approximately 3 years 7 months
Participants receive treatment with either pembrolizumab, amivantamab, and carboplatin or pembrolizumab, 5-flurouracil, and carboplatin or cisplatin as part of the study.
Visits occur regularly during treatment as per study schedule
Trial Site Locations
Total: 186 locations
1
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Providence St Jude Medical Center
Fullerton, California, United States, 92835
Actively Recruiting
3
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
4
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States, 92562
Actively Recruiting
5
Stanford University Medical Center
Stanford, California, United States, 94304
Actively Recruiting
6
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
7
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Florida Cancer Specialists South
Fort Myers, Florida, United States, 33901
Actively Recruiting
9
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
11
Florida Cancer Specialists North Region
St. Petersburg, Florida, United States, 33701-4553
Actively Recruiting
12
Florida Cancer Specialists East
West Palm Beach, Florida, United States, 33401-3406
Actively Recruiting
13
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
14
Central Georgia Cancer Care
Macon, Georgia, United States, 31210
Actively Recruiting
15
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States, 60607
Actively Recruiting
16
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States, 62269
Actively Recruiting
18
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
19
University of Marlyand Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
20
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
21
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201 2013
Actively Recruiting
22
Washington University School Of Medicine
St Louis, Missouri, United States, 63108
Actively Recruiting
23
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States, 68506
Actively Recruiting
24
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
25
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
26
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
27
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
28
Bronx Veterans Affairs Medical Center
The Bronx, New York, United States, 10468
Actively Recruiting
29
Carolina Cancer Research Center
Wilson, North Carolina, United States, 27893
Actively Recruiting
30
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
31
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
32
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
33
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
34
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
35
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
36
Texas Oncology - San Antonio
Fredericksburg, Texas, United States, 78624
Actively Recruiting
37
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
38
Texas Oncology-Central South
Waco, Texas, United States, 76712
Actively Recruiting
39
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
40
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
41
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
42
Monash Medical Centre
Clayton, Australia, 3168
Actively Recruiting
43
Liverpool Hospital
Liverpool, Australia, 2170
Actively Recruiting
44
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
45
St John of God Hospital Murdoch
Murdoch, Australia, 6150
Actively Recruiting
46
GenesisCare
St Leonards, Australia, 2065
Actively Recruiting
47
Tirol Kliniken MedUni Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
48
Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart
Oberwart, Austria, A-7400
Actively Recruiting
49
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria, A-5020
Actively Recruiting
50
University Hospital St. Poelten
Sankt Pölten, Austria, A-3100
Actively Recruiting
51
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
52
Chu Helora Hospital La Louviere Site Jolimont
Haine-Saint-Paul, Belgium, 7100
Actively Recruiting
53
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
54
Vitaz
Sint-Niklaas, Belgium, 9100
Actively Recruiting
55
Institut Roi Albert II
Woluwe-Saint-Lambert, Belgium, 1200
Actively Recruiting
56
Fundacao Doutor Amaral Carvalho
Jaú, Brazil, 17210 080
Actively Recruiting
57
Liga Norte Riograndense Contra O Cancer
Natal, Brazil, 59062 000
Actively Recruiting
58
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90020 090
Actively Recruiting
59
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pesquisa
São José do Rio Preto, Brazil, 15090-0000
Actively Recruiting
60
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01323 903
Actively Recruiting
61
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, Brazil, 29043 260
Actively Recruiting
62
Tongren Hospital Outpatient Bldg
Beijing, China, 100051
Actively Recruiting
63
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
64
The Affiliated Hospital of Bengbu Medical College
Bengbu, China, 233099
Actively Recruiting
65
The second Xiangya Hospital of Central South University
Changsha, China, 410011
Actively Recruiting
66
Hunan Cancer hospital
Changsha, China, 410013
Actively Recruiting
67
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
68
West China Hospital Sichuan University
Chengdu, China, 610041
Actively Recruiting
69
Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
70
Chongqing Cancer Hospital
Chongqing, China, 400015
Actively Recruiting
71
Dongguan People s Hospital
Dongguan, China, 523063
Actively Recruiting
72
Sun Yat-sen University Cancer Hospital
Guangzhou, China, 510060
Actively Recruiting
73
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
74
The Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China, 250117
Actively Recruiting
75
Yunnan Cancer Hospital
Kunming, China, 650100
Actively Recruiting
76
Linyi Cancer Hospital
Linyi, China, 276002
Actively Recruiting
77
Nanjing Drum Tower Hospital
Nanjing, China, 210009
Actively Recruiting
78
The Cancer Hospital Affiliated to Guangxi Medical University
Nanning, China, 530021
Actively Recruiting
79
Fudan Cancer Hospital
Shanghai, China, 200032
Actively Recruiting
80
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
81
Tongji Hospital, Tongji Medical College of HUST
Wuhan, China, 430030
Actively Recruiting
82
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China, 430048
Actively Recruiting
83
Wuhan University - Zhongnan Hospital
Wuhan, China, 430071
Actively Recruiting
84
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China, 710061
Actively Recruiting
85
Yibin Second People's Hospital
Yibin, China, 644609
Actively Recruiting
86
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
87
University Hospital Olomouc
Olomouc, Czechia, 779 00
Actively Recruiting
88
University Hospital Ostrava
Ostrava, Czechia, 708 00
Actively Recruiting
89
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 00
Actively Recruiting
90
Motol University Hospital
Prague, Czechia, 150 06
Actively Recruiting
91
Krajska nemocnice T. Bati, a.s.
Zlín, Czechia, 760 01
Actively Recruiting
92
Institut Sainte Catherine
Avignon, France, 84918
Actively Recruiting
93
Clinique Victor Hugo
Le Mans, France, 72000
Actively Recruiting
94
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
95
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
Marseille, France, 13005
Actively Recruiting
96
Institut Curie
Paris, France, 75005
Actively Recruiting
97
Assistance Publique - Hopitaux de Paris
Paris, France, 75012
Actively Recruiting
98
Centre Henri Becquerel
Rouen, France, 76000
Actively Recruiting
99
Institut Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
100
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
101
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany, 35392
Actively Recruiting
102
Klinikum Region Hannover Klinikum Siloah
Hanover, Germany
Actively Recruiting
103
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
104
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
105
Universitätsmedizin Rostock Zentrum für Innere MedizinKlinik III
Rostock, Germany, 18057
Actively Recruiting
106
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Actively Recruiting
107
Semmelweis Egyetem
Budapest, Hungary, 1083
Actively Recruiting
108
Orszagos Onkologiai Intezet
Budapest, Hungary, 1122
Actively Recruiting
109
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
110
Gyor Moson Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary, 9024
Actively Recruiting
111
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary, 7624
Actively Recruiting
112
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Hungary, 3100
Actively Recruiting
113
Apollo Speciality Hospital, Chennai
Chennai, India, 600035
Actively Recruiting
114
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, India, 302017
Actively Recruiting
115
HealthCare Global HCG Manavata Cancer Centre
Nashik, India, 422002
Actively Recruiting
116
All India Institute of Medical Sciences
New Delhi, India, 110029
Actively Recruiting
117
Kailash Cancer Hospital and Research Centre
Vadodara, India, 391760
Actively Recruiting
118
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
119
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
120
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy, 80131
Actively Recruiting
121
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
122
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, Italy, 27100
Actively Recruiting
123
AOU Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
124
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
125
Kansai Medical University Hospital
Hirakata, Japan, 573 1191
Actively Recruiting
126
National Cancer Center Hospital East
Kashiwa, Japan, 277 8577
Actively Recruiting
127
Hokkaido University Hospital
Sapporo, Japan, 060 8648
Actively Recruiting
128
Tokyo Medical University Hospital
Shinjuku, Japan, 160 0023
Actively Recruiting
129
Shizuoka Cancer Center
Sunto Gun, Japan, 411 8777
Actively Recruiting
130
National Cancer Center Hospital
Tokyo, Japan, 104 0045
Actively Recruiting
131
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135 8550
Actively Recruiting
132
CO de Chihuahua
Chihuahua City, Mexico, 31217
Actively Recruiting
133
Act. Basada en la Inv. Del Ca
Guadalajara, Mexico, 44680
Actively Recruiting
134
P. y S. Oncologicos Acacias
Mexico City, Mexico, 03240
Actively Recruiting
135
Gefarma Atrys
Mexico City, Mexico, 11510
Actively Recruiting
136
Cuidados Oncologicos
Querétaro, Mexico, 76000
Actively Recruiting
137
Find My Cancer Cen de Inv Clin
Tijuana, Mexico, 22010
Actively Recruiting
138
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
139
Maastricht UMC
Maastricht, Netherlands, 6229 HX
Actively Recruiting
140
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 214
Actively Recruiting
141
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, Poland, 44-102
Actively Recruiting
142
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland, 93-513
Actively Recruiting
143
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, Poland, 20-090
Actively Recruiting
144
Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
Poznan, Poland, 61-866
Actively Recruiting
145
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02-781
Actively Recruiting
146
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal, 1649 028
Actively Recruiting
147
Hosp. Cuf Descobertas
Lisbon, Portugal, 1998-018
Actively Recruiting
148
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, Portugal, 8500-338
Actively Recruiting
149
Instituto Portugues de Oncologia
Porto, Portugal, 4200-072
Actively Recruiting
150
Uls Gaia Espinho
Vila Nova de Gaia, Portugal, 4434 502
Actively Recruiting
151
Spitalul Clinic Coltea
Bucharest, Romania, 030167
Actively Recruiting
152
Cardiomed
Cluj-Napoca, Romania, 400015
Actively Recruiting
153
Institutul Oncologic 'Prof Dr. Ion Chiricuta' Cluj-Napoca
Cluj-Napoca, Romania, 400015
Actively Recruiting
154
Clinica de Oncologie Sf Nectarie
Craiova, Romania, 200542
Actively Recruiting
155
Institutul Regional de Oncologie Iasi
Iași, Romania, 700483
Actively Recruiting
156
Oncocenter Oncologie Clinica SRL
Timișoara, Romania, 300166
Actively Recruiting
157
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
158
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
159
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
160
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
161
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
162
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
163
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
164
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
165
Complejo Hosp de Navarra - Hosp de Navarra
Pamplona, Spain, 31008
Actively Recruiting
166
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
167
Hosp. Gral. Univ. Valencia
Valencia, Spain, 46014
Actively Recruiting
168
Hosp. Univ. Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
169
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
170
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
171
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 833
Actively Recruiting
172
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
173
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
174
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
175
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
176
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
177
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
178
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
179
Guy's and St Thomas' NHS Foundation Trust
Greater London, United Kingdom, SE1 9RT
Actively Recruiting
180
Royal Surrey County Hospital NHS Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
181
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
182
Royal Marsden Hospital Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
183
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
184
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Actively Recruiting
185
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
186
The Royal Marsden NHS Trust Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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