Clinical Trials | 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

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Metastatic Head and Neck Squamous Cell Carcinoma that have received no prior anti-EGFR therapy and anti-MET therapy in any setting. The purpose of this study is to see how well a treatment that includes amivantamab, pembrolizumab and carboplatin works compared to a different treatment that includes 5-FU, pembrolizumab and platinum (carboplatin or cisplatin) therapy. In this study, you will be assigned to one of the following groups: ? Arm A: amivantamab + pembrolizumab + carboplatin ? Arm B: pembrolizumab + carboplatin or cisplatin + 5-FU In Arm B, your study doctor will discuss with you whether carboplatin or cisplatin is most appropriate for your treatment. The possible discomforts, side effects, and risks related to the study treatment drugs are not all known. Most side effects are not serious. Some may be serious, life-threatening, or could lead to death and may require treatment or additional testing. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. You may receive study treatment for up to a maximum of 24 months. You will need to visit the site typically every 3 weeks during your participation. Follow-up visits may occur after stopping the study treatment. Additional information found here: https://clinicaltrials.gov/study/NCT07276399?titles=OrigAMI-5&rank=1 For questions, contact: [email protected]