The Phase 3 trial (NCT04949256) investigating pembrolizumab plus lenvatinib plus chemotherapy for participants with metastatic esophageal carcinoma reached its primary completion on 2025-05-08. This study, known as LEAP-014, aims to assess the efficacy and safety of the combination therapy as a first-line intervention.
Background
The trial focuses on metastatic esophageal squamous cell carcinoma, a serious cancer. The study investigates a combination of pembrolizumab, lenvatinib, and chemotherapy agents including cisplatin, 5-fu, and oxaliplatin.
Trial design
The LEAP-014 study (NCT04949256) is a Phase 3, randomized trial that enrolled 864 participants. The study investigates the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy as a first-line intervention for participants with metastatic esophageal carcinoma. The primary hypothesis is that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
What this means
The primary completion of the LEAP-014 trial indicates that the main data collection phase for the study's primary endpoint, overall survival, has concluded. Researchers will now proceed with data analysis to determine the efficacy and safety profile of the combination therapy for metastatic esophageal carcinoma. The results of this Phase 3 study will provide crucial insights into potential new first-line treatment options for this patient population.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04949256, titled "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)," was posted on 2025-05-08 on clinicaltrials.gov.