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Recruiting NCT07276399

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

Phase III Interventional Squamous Cell Carcinoma of Head and Neck

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amivantamab, Pembrolizumab, Carboplatin, 5-Flurouracil.
Who it may be relevant to
Registry conditions: Squamous Cell Carcinoma of Head and Neck. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Belgium, Brazil +17
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants With Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Overview

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

Interventions

  • Biological Amivantamab
    Amivantamab will be administered.
  • Biological Pembrolizumab
    Pembrolizumab will be administered.
  • Drug Carboplatin
    Carboplatin will be administered.
  • Drug 5-Flurouracil
    5-Flurouracil will be administered for over 4-day infusion period.
  • Drug Cisplatin
    Cisplatin will be administered.

Primary outcome measures

  • Overall Survival (OS) [Time frame: Up to approximately 3 years 7 months]
  • Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to approximately 3 years 7 months]
Secondary outcome measures (12)
  • Progression-Free Survival (PFS) Using RECIST Version 1.1, as Assessed by BICR [Time frame: Up to approximately 3 years 7 months]
  • Duration of Response (DOR) As Assessed by BICR [Time frame: Up to approximately 3 years 7 months]
  • ORR as Assessed by Investigator [Time frame: Up to approximately 3 years 7 months]
  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 3 years 7 months]
  • Number of Participants with Laboratory Abnormalities [Time frame: Up to approximately 3 years 7 months]
  • Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module 43 (EORTC QLQ-HN43) Symptom Scale Score [Time frame: Baseline, up to approximately 3 years 7 months]
  • Percentage of Participants with Improved or Stable Symptoms Compared to Baseline as Measured by EORTC QLQ-Core (C) 30 Symptom Scale Score [Time frame: Baseline, up to approximately 3 years 7 months]
  • Change from Baseline in Functioning HRQoL, as Measured by Functioning Scales of the EORTC QLQ-C30 [Time frame: Baseline, up to approximately 3 years 7 months]
  • Change from Baseline in Overall HRQoL, as Measured by Global Health Scales of the EORTC QLQ-C30 [Time frame: Baseline, up to approximately 3 years 7 months]
  • Differences Between Treatment Groups (Arms A and B) for EORTC Quality of Life (QLG) Item Library-46 (IL-46) Tolerability Scale Scores [Time frame: Up to approximately 3 years 7 months]
  • Serum Concentration of Amivantamab [Time frame: Up to approximately 3 years 7 months]
  • Number of Participants with Serum Anti-Amivantamab Antibodies [Time frame: Up to approximately 3 years 7 months]

Eligibility criteria

Inclusion criteria

  • Be more than or equal to (>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater)
  • 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 an uncontrolled illness
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 46 centers
  • Ironwood Cancer and Research Center — Chandler
  • University of Arizona Cancer Center — Tucson
  • Providence St Jude Medical Center — Fullerton
  • Scripps Health — La Jolla
  • Valkyrie Clinical Trials — Los Angeles
  • University of California, Los Angeles UCLA — Los Angeles
  • Valkyrie Clinical Trials Murrieta — Murrieta
  • University Of California - Davis — Sacramento
  • … and 38 more centers
China · 25 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Tongren Hospital Outpatient Bldg — Beijing
  • Beijing Cancer Hospital — Beijing
  • The Affiliated Hospital of Bengbu Medical College — Bengbu
  • The second Xiangya Hospital of Central South University — Changsha
  • Hunan Cancer hospital — Changsha
  • Sichuan Cancer Hospital — Chengdu
  • West China Hospital Sichuan University — Chengdu
  • … and 17 more centers
United Kingdom · 11 centers

Center list to be confirmed — check the primary protocol.

Germany · 9 centers

Center list to be confirmed — check the primary protocol.

France · 8 centers

Center list to be confirmed — check the primary protocol.

Japan · 8 centers

Center list to be confirmed — check the primary protocol.

Spain · 8 centers

Center list to be confirmed — check the primary protocol.

Italy · 7 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 7 centers

Center list to be confirmed — check the primary protocol.

Brazil · 6 centers
  • Fundacao Doutor Amaral Carvalho — Jaú
  • Liga Norte Riograndense Contra O Cancer — Natal
  • Irmandade da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto - Centro Integrado de Pes — São José do Rio Preto
  • Hospital Alemao Oswaldo Cruz — São Paulo
  • Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia — Vitória
Czechia · 6 centers

Center list to be confirmed — check the primary protocol.

Hungary · 6 centers

Center list to be confirmed — check the primary protocol.

India · 6 centers

Center list to be confirmed — check the primary protocol.

Mexico · 6 centers

Center list to be confirmed — check the primary protocol.

Poland · 6 centers

Center list to be confirmed — check the primary protocol.

Romania · 6 centers

Center list to be confirmed — check the primary protocol.

Australia · 5 centers
  • Monash Medical Centre — Clayton
  • Liverpool Hospital — Liverpool
  • Peter MacCallum Cancer Centre — Melbourne
  • St John of God Hospital Murdoch — Murdoch
  • GenesisCare — St Leonards
Austria · 5 centers
  • Tirol Kliniken MedUni Innsbruck — Innsbruck
  • Burgenlaendische Krankenanstalten Gesellschaft M B H Klinik Oberwart — Oberwart
  • Universitaetsklinikum Salzburg Landeskrankenhaus — Salzburg
  • University Hospital St. Poelten — Sankt Pölten
  • Medical University Vienna MUV — Vienna
Belgium · 5 centers
  • UZ Antwerpen — Edegem
  • Chu Helora Hospital La Louviere Site Jolimont — Haine-Saint-Paul
  • Universitair Ziekenhuis Leuven — Leuven
  • Vitaz — Sint-Niklaas
  • Institut Roi Albert II — Woluwe-Saint-Lambert
Portugal · 5 centers

Center list to be confirmed — check the primary protocol.

South Korea · 4 centers

Center list to be confirmed — check the primary protocol.

Netherlands · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07276399 · 61186372HNC3001 · 61186372HNC3001 · 2025-521917-24-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗