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 (Jun 2026). This Phase 3 trial studies multiple treatments for squamous cell carcinoma of head and neck.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
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
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 →Frequently asked questions
Is NCT07276399 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CDKN2A?
Yes, CDKN2A wild-type is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV wild-type is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify