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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
NCT07276399 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- BIOLOGICAL Amivantamab
- DRUG 5-Flurouracil
Study Locations (20)
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health — New York
- Montefiore Medical Center — The Bronx
- Bronx Veterans Affairs Medical Center — The Bronx
California
- Providence St Jude Medical Center — Fullerton
- Valkyrie Clinical Trials — Los Angeles
- Valkyrie Clinical Trials Murrieta — Murrieta
Illinois
- Rush University Medical Center Rush University Cancer Center Chicago — Chicago
- The University of Chicago Medical Center (UCMC) — Chicago
- Cancer Care Specialists of Central Illinois — O'Fallon
Connecticut
- Hartford Hospital — Hartford
- Yale Cancer Center — New Haven
Georgia
- Emory University — Atlanta
- Central Georgia Cancer Care — Macon
Kentucky
- University of Kentucky Medical Center — Lexington
Michigan
- Karmanos Cancer Institute — Detroit
Missouri
- Washington University School Of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-12-03 |
| Est. Completion | 2029-06-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07276399
The ClinicalTrials.gov registry entry for NCT07276399 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07276399 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07276399 about?
NCT07276399 is a clinical study titled "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". 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 (H...
What is the current status of trial NCT07276399?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2025-12-03. Estimated completion is 2029-06-18.
What conditions does trial NCT07276399 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07276399?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Amivantamab (BIOLOGICAL), 5-Flurouracil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07276399?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07276399 being conducted?
This trial has 20 study locations across California, Connecticut, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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