NCT06385080

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

A Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Other Therapeutic Agents in Participants With Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 287 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Amivantamab	Amivantamab will be administered subcutaneously.
BIOLOGICAL	Pembrolizumab	Pembrolizumab will be administered intravenously.
DRUG	Paclitaxel	Paclitaxel will be administered intravenously.
DRUG	Carboplatin	Carboplatin will be administered intravenously.

Timeline

• Start date: 2024-04-22
• Primary completion: 2027-12-27
• Completion: 2032-12-27
• First posted: 2024-04-25
• Last updated: 2026-04-13

Locations

55 sites across 11 countries: United States, China, France, Germany, Japan, Malaysia, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study