Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-20-003
Prinicipal Investigator
Almokadem, Salah
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
LEAP-009 / MK-7902- 009-00 (E7080-G000-228)
Title
A Phase II, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)
Objective
Primary Objective: to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to ORR per RECIST 1.1 as assessed by BICR. Hypothesis (H1): pembrolizumab + lenvatinib is superior to SOC with respect to ORR per RECIST 1.1 by BICR.

Primary Endpoints: Objective Response (OR): complete response (CR) or partial response (PR).

Secondary Objectives:- Objective: to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to PFS per RECIST 1.1 by BICR.

Objective: to compare pembrolizumab + lenvatinib combination therapy and SOC chemotherapy with respect to OS.

Secondary Endpoints:- PFS: The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
OS: The time from randomization to death due to any cause.
Applicable Disease Sites
Head and Neck
Status
Open
Participating Institutions
Hershey Medical Center