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) (KEYNOTE-010)
Phase 3
Completed
NCT04199104
| Condition | Head and Neck Squamous Cell Carcinoma |
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| Phase | Phase 3 |
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| Sponsor | Merck Sharp & Dohme LLC |
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| Status | Completed |
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| Enrollment | 511 participants |
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| Interventions | Lenvatinib, Pembrolizumab |
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| Start date | Feb 5, 2020 |
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| Completion date | May 30, 2023 |
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| Results posted | Jul 16, 2024 |
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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).
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Up to ~ 37 months · Percentage of participants
| Pembrolizumab + Lenvatinib | 46.9 Percentage of participants |
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| Pembrolizumab + Placebo | 27.5 Percentage of participants |
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| p-value | 0.0000019 |
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| point estimate | 19.3 (95% CI 11.2–27.3) |
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 7.0 Months |
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| Pembrolizumab + Placebo | 2.8 Months |
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| p-value | 0.0001129 |
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| Hazard Ratio (HR) | 0.68 (95% CI 0.55–0.83) |
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Overall Survival (OS)
Up to ~ 37 months · Months
| Pembrolizumab + Lenvatinib | 15.0 Months |
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| Pembrolizumab + Placebo | 17.9 Months |
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| p-value | 0.8819584 |
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| Hazard Ratio (HR) | 1.15 (95% CI 0.91–1.45) |
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Open in BENITIONS
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