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NCT07276399 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 3
Development phase
500
Enrollment target
20
Study locations

NCT07276399: Recruiting Phase 3 study of Squamous Cell Carcinoma of Head and Neck, sponsored by Janssen Research & Development.

NCT07276399 is a Phase 3 study of Squamous Cell Carcinoma of Head and Neck that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 500 participants, above the 157-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (218% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07276399, a Phase 3 study of Squamous Cell Carcinoma of Head and Neck, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 3
Development phase
500 participants
Enrollment target
20
Study locations

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.

Primary Outcome

OS is defined as time from the date of randomization to the date of death due to any cause.

Conditions Studied

Squamous Cell Carcinoma of Head and Neck

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

FieldValue
Enrollment Target 500 participants
Start Date 2025-12-03
Est. Completion 2029-06-18
Phase Phase 3
Janssen Research & Development

593 total trials

What NCT07276399 shows while recruiting

NCT07276399 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 157-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (218% higher).

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.

NCT07276399 names 20 study sites across 11 states, led by New York, California, Illinois.

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.

What interventions are being tested in trial NCT07276399?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Cisplatin (DRUG), Amivantamab (BIOLOGICAL), 5-Flurouracil (DRUG).

Who is sponsoring clinical trial NCT07276399?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Squamous Cell Carcinoma of Head and Neck

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07276399's enrollment target sits among peer trials

500 4th of 37 higher than 34 of 37 other Squamous Cell Carcinoma of Head and Neck trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07276399

Source: ClinicalTrials.gov NCT07276399, the US trial registry maintained by the National Library of Medicine. NCT07276399 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.