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
NCT ID: NCT07276399
Last Updated: 2025-12-19
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
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-12-03
2029-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Pembrolizumab, Amivantamab, Carboplatin
Participants will receive pembrolizumab, amivantamab and carboplatin.
Amivantamab
Amivantamab will be administered.
Pembrolizumab
Pembrolizumab will be administered.
Carboplatin
Carboplatin will be administered.
Arm B: Pembrolizumab, 5-Flurouracil (5-FU), Carboplatin or Cisplatin
Participants will receive pembrolizumab, 5-FU and carboplatin or cisplatin (platinum therapy).
Pembrolizumab
Pembrolizumab will be administered.
Carboplatin
Carboplatin will be administered.
5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.
Cisplatin
Cisplatin will be administered.
Interventions
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Amivantamab
Amivantamab will be administered.
Pembrolizumab
Pembrolizumab will be administered.
Carboplatin
Carboplatin will be administered.
5-Flurouracil
5-Flurouracil will be administered for over 4-day infusion period.
Cisplatin
Cisplatin will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have histologically or cytologically confirmed recurrent/metastatic (R/M) HNSCC that is considered incurable by local therapies: a. eligible primary tumor locations are the oral cavity, oropharynx, hypopharynx, or larynx; b. Must not have a primary tumor site of nasopharynx or primary tumor of unknown location; c. Must have documented local testing results per local regulations; d. Human papillomavirus (HPV) status must be known for participants with primary tumor location in oropharynx via p16 test, HPV DNA test, or high-risk HPV in situ hybridization (ISH). Any known p16, HPV DNA, or high-risk HPV ISH status of tumor must be negative
* Be treatment-naive for systemic therapy in the R/M setting
* Have an ECOG performance status of 0 or 1
* Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1
Exclusion Criteria
* Have untreated brain metastases or history of known presence of leptomeningeal disease
* Have a history of clinically significant cardiovascular disease
* Inadequate organ or bone marrow function
* Known allergies, hypersensitivity, contraindications, or intolerance to excipients of: Amivantamab, Pembrolizumab, Carboplatin, Cisplatin, 5-FU and Hyaluronidase
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Providence St Jude Medical Center
Fullerton, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Central Georgia Cancer Care
Macon, Georgia, United States
Cancer Care Specialists of Central Illinois
O'Fallon, Illinois, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Cancer Research Center
Wilson, North Carolina, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists
Arlington, Virginia, United States
St John of God Hospital Murdoch
Murdoch, , Australia
Fundacao Doutor Amaral Carvalho
Jaú, , Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pesquisa
São José do Rio Preto, , Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, , Brazil
Shanghai East Hospital
Shanghai, , China
Hokkaido University Hospital
Sapporo, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
St Bartholomew's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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61186372HNC3001
Identifier Type: OTHER
Identifier Source: secondary_id
2025-521917-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
61186372HNC3001
Identifier Type: -
Identifier Source: org_study_id