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) (LEAP-010) (MK-7902-010)

Official Title

A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

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 Tumours 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).

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
• Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).
• Overall Survival (OS)

• Duration of Response (DOR)
• Number of Participants Who Experienced an Adverse Event (AE)
• Number of Participants Who Discontinued Study Drug Due to an AE

View this trial on ClinicalTrials.gov