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OncoMatch/Clinical Trials/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

Is NCT07276399 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for squamous cell carcinoma of head and neck.

Phase 3RecruitingJanssen Research & Development, LLCNCT07276399Data as of May 2026

Treatment: Amivantamab · Pembrolizumab · Carboplatin · 5-Flurouracil · Cisplatin — 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CDKN2A wild-type

Any known p16 ... status of tumor must be negative

Required: HPV wild-type

Any known ... HPV DNA ... status of tumor must be negative

Required: HPV wild-type

Any known ... high-risk HPV ISH status of tumor must be negative

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Providence St Jude Medical Center · Fullerton, California
  • Valkyrie Clinical Trials · Los Angeles, California
  • Valkyrie Clinical Trials Murrieta · Murrieta, California
  • Hartford Hospital · Hartford, Connecticut
  • Yale Cancer Center · New Haven, Connecticut

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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