Trials / Recruiting
RecruitingNCT07276399
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, 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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-03
- Primary completion
- 2029-06-18
- Completion
- 2029-06-18
- First posted
- 2025-12-11
- Last updated
- 2026-04-13
Locations
160 sites across 21 countries: United States, Australia, Austria, Belgium, Brazil, China, Czechia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07276399. Inclusion in this directory is not an endorsement.