Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal
Carcinoma
NCT Number:
NCT04949256
Phase:
III
Protocol Type:
Treatment
Age Group:
Adults
Disease Sites:
Stomach
Study Objectives:
Part 1 (FP and TP Safety Run-in): To evaluate the safety and tolerability of treatment with lenvatinib + pembrolizumab in combination with FP or TP. Part 2 (Main Study): To compare OS between treatment arms. Part 2 (Main Study): To compare PFS per RECIST 1.1, as determined by blinded independent central review (BICR), between treatment arms. Part 2 (Main Study): To compare ORR per RECIST 1.1, as determined by BICR, between treatment arms. Part 2 (Main Study): To evaluate DOR per RECIST 1.1, as determined by BICR, between treatment arms. Part 2 (Main Study): To compare OS and PFS, ORR, DOR, per RECIST 1.1 assessed by BICR between treatment arms in participants whose tumors are PD-L1 CPS≥ 10. Part 2 (Main Study): To evaluate the safety and tolerability profile of lenvatinib + pembrolizumab in combination with chemotherapy versus pembrolizumab + chemotherapy. Part 2 (Main Study): To compare lenvatinib + pembrolizumab in combination with chemotherapy compared with pembrolizumab + chemotherapy with respect to mean change from baseline in healthrelated quality of life (HRQoL) using the EORTC QLQ-C30 and QLQ-OES18. Part 2 (Main Study): To compare lenvatinib + pembrolizumab in combination with chemotherapy compared with pembrolizumab + chemotherapy with respect to time to deterioration (TTD) in HRQoL using the EORTC QLQ-C30 and QLQOES18.
Study Documents
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