A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010/LEAP-010)-China Extension
Summary
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Timeline
- Start
- 2020-10-30
- Primary completion
- 2023-08-25
- Completion
- 2025-03-28
Outcome
Mixed primary results
registry analysis (other test); Pembrolizumab + Lenvatinib vs Pembrolizumab + Placebo; p = 0.0002014; Estimate difference 29.5 (95% CI 14.0 to 43.9); Unstratified Miettinen & Nurminen method NCT05523323 ↗
registry analysis (other test); Pembrolizumab + Lenvatinib vs Pembrolizumab + Placebo; p = 0.0000037; Hazard Ratio (HR) 0.34 (95% CI 0.21 to 0.55); unstratified Log-rank test. NCT05523323 ↗
registry analysis (other test); Pembrolizumab + Lenvatinib vs Pembrolizumab + Placebo; p = 0.30933; Hazard Ratio (HR) 0.86 (95% CI 0.49 to 1.54); Unstratified Log-rank test NCT05523323 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |