At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed new diagnosis of oropharyngeal (p16+ or p16−), larynx, hypopharynx, or unresectable oral cavity squamous cell carcinoma
- ✓Tissue provided for PD-L1 biomarker analysis from core or excisional biopsy
- ✓Evaluable tumor burden (measurable and/or non-measurable lesions) on CT or MRI per RECIST 1.1
- ✓Eligible for definitive chemoradiation therapy and not candidate for primary surgery per investigator decision
- ✕Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or co-inhibitory T-cell receptor agents
- ✕Prior systemic therapy, targeted therapy, radiotherapy, or radical surgery for the head and neck cancer under study
- ✕Active Hepatitis B or C
- ✕Known history of HIV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab, Placebo, and 3 other interventions for Head and Neck Neoplasms. Completed, enrolled 804 participants across 151 sites in 21 countries.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).
Study Details
Timeline
Interventions
Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
Normal saline or dextrose solution administered as an IV infusion Q3W
100 mg/m\^2 administered as an IV infusion Q3W
70 Gray (Gy) given in 35 fractions over 6 weeks
70 Gy given in 35 fractions over 7 weeks