At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed resectable, non-metastatic squamous cell carcinoma of oropharynx (stage III HPV+ with T4/N0-2/M0, or stage III-IVA HPV negative), or stage III-IVA larynx/hypopharynx/oral cavity
- ✓Eligible for primary surgery per investigator assessment
- ✓Evaluable tumor burden by CT or MRI per RECIST 1.1
- ✓Newly obtained tumor biopsy (core or excisional) from non-previously irradiated lesion
- ✕Stage T4B and/or N3 disease, or distant metastases
- ✕Primary tumor location outside oropharynx, larynx, hypopharynx, or oral cavity (e.g., nasopharyngeal, sinus, unknown primary)
- ✕Prior PD-1/PD-L1/PD-L2 inhibitors or other co-inhibitory T-cell receptor agents
- ✕Prior radiotherapy or systemic anticancer therapy for the HNC under study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab 200 mg, Radiotherapy 60 Gray, and 3 other interventions for Head and Neck Neoplasms. Active but no longer recruiting, targeting 714 participants across 192 sites in 24 countries.
Detailed Summary
This is a randomized, active-controlled, open-label study of pembrolizumab given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Study Details
Timeline
Interventions
200 mg administered IV infusion on Day 1 of each 21-day cycle
Low risk participants administered 2 Gray in 30 fractions. Administered using intensity modulated radiation therapy.
High risk participants administered 2 Gray in 33 fractions. Administered using intensity modulated radiation therapy.
Participants with gross residual disease administered 2 Gray in 35 fractions. Administered using intensity modulated radiation therapy.
100 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle