OrigAMI-5
Head and neck cancer
A Phase 3, randomized, open-label study of amivantamab (EGFR × MET bispecific Ab) in addition to standard-of-care agents in participants with recurrent/metastatic HNSCC
Phase
Compound
Amivantamab (EGFR × MET bispecific Ab) + pembrolizumab + carboplatin
NCT identifier
NCT07276399
Enrollment
N=~500
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- Age ≥18 years
- Recurrent or metastatic HNSCC that is considered incurable
- Treatment naive for systemic therapy in the recurrent/metastatic setting
- ECOG PS 0 or 1
- Measurable disease according to RECIST v1.1
Study
design
Primary outcomes:
- OS
- ORR by BICR
Secondary outcomes†:
- PFS
- DOR
- ORR by investigator
- Safety
- HRQoL
*Not a complete list of inclusion and exclusion criteria. †Not a complete list of outcomes.
Ab,
antibody; BICR, blinded independent central review; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology
Group performance status; EGFR, epidermal growth factor receptor; HNSCC, head and neck squamous cell
carcinoma; HRQoL, health-related quality of life; MET, mesenchymal epithelial transition; ORR, objective response
rate; OS, overall survival; PFS, progression-free survival; RECIST v1.1, Response Evaluation Criteria in Solid
Tumors version 1.1; SC, subcutaneous.