Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
Overall Survival (OS)
Detailed description
1. PFS (using RECIST v1.1), as assessed by BICR, 2. ORR as assessed by BICR, 3. DOR as assessed by BICR, 4. ORR as assessed by the investigator, 5. Incidence and severity of TEAEs and laboratory abnormalities, 6. Proportion of participants with improved or stable symptoms relative to baseline, as measured by the EORTC QLQ-HN43 and symptom scales of the EORTC QLQ-C30, 7. Change from baseline in functioning and overall HRQoL, as measured by functioning and global health scales of the EORTC QLQC30, 8. Differences between treatment groups in the EORTC IL46 tolerabilityscale scores, 9. Serum amivantamab concentrations and serum anti-amivantamab antibodies
Interventions
Sponsors
Janssen Cilag International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PFS (using RECIST v1.1), as assessed by BICR, 2. ORR as assessed by BICR, 3. DOR as assessed by BICR, 4. ORR as assessed by the investigator, 5. Incidence and severity of TEAEs and laboratory abnormalities, 6. Proportion of participants with improved or stable symptoms relative to baseline, as measured by the EORTC QLQ-HN43 and symptom scales of the EORTC QLQ-C30, 7. Change from baseline in functioning and overall HRQoL, as measured by functioning and global health scales of the EORTC QLQC30, 8. Differences between treatment groups in the EORTC IL46 tolerabilityscale scores, 9. Serum amivantamab concentrations and serum anti-amivantamab antibodies | — |
Countries
Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed