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ACTIVE NOT RECRUITING
NCT04207086
PHASE2

A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma

Sponsor: Melanoma Institute Australia

View on ClinicalTrials.gov

Summary

In many cancers, early stage diagnosis and early treatment offers the best chance of a prolonged recurrence free- and overall survival. In stage III/IV resectable melanoma, an opportunity exists to improve outcomes with the addition of neoadjuvant and adjuvant systemic therapy as an adjunct to surgery. Neoadjuvant clinical trials for resectable but bulky stage III/IV melanoma allows for the efficient and rapid evaluation of drug activity in humans utilising multiple clinical endpoints of metabolic, radiological and pathological response; relapse-free survival; overall survival.

Official title: A Phase II, Open Label, Single Arm Study of Neoadjuvant Pembrolizumab and Lenvatinib for Patients With Resectable Stage III Melanoma

Key Details

Gender

All

Age Range

18 Years - 115 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2020-11-11

Completion Date

2033-01-01

Last Updated

2025-12-16

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

DRUG

Lenvatinib

Lenvatinib is an oral potent multiple RTK inhibitor that selectively inhibits VEGF receptors, VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), fibroblast growth factor receptor (FGFR1-4), platelet derived growth factor (PDGFRα), stem cell factor receptor (KIT), and rearranged during transfection (RET).

Locations (1)

Melanoma Institute Australia

North Sydney, New South Wales, Australia