Stage III-IVA Resectable Locoregionall Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Conditions
Brief summary
MPR as assessed by external independent pathology review (IPR) is defined as ≤10% invasive squamous cell carcinoma (SCC) within the resected primary tumor specimen and all sampled regional lymph nodes
Detailed description
Pathological complete response (pCR) as assessed by external IPR at the time of definitive surgery is defined as no residual invasive SCC within the resected primary tumor specimen and all sampled regional lymph nodes, pCR per local assessment for pathological review, MPR per local assessment for pathological review, EFS is defined as the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated, or death due to any cause, OS is defined as the time from randomization to death due to any cause, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Ascendis Pharma Oncology Division A/S
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR as assessed by external independent pathology review (IPR) is defined as ≤10% invasive squamous cell carcinoma (SCC) within the resected primary tumor specimen and all sampled regional lymph nodes | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) as assessed by external IPR at the time of definitive surgery is defined as no residual invasive SCC within the resected primary tumor specimen and all sampled regional lymph nodes, pCR per local assessment for pathological review, MPR per local assessment for pathological review, EFS is defined as the time from the date of randomization to the date of first record of any of the following events: disease progression; local or distant recurrence as assessed with imaging or biopsy as indicated, or death due to any cause, OS is defined as the time from randomization to death due to any cause, Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | — |
Countries
Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed