Last updated on July 2019

A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab or With Spartalizumab and Carboplatin or With Carboplatin in Patients With Advanced Triple-negative Breast Cancer


Brief description of study

The purpose of this study is to assess the efficacy, safety, and PK characteristics of the following three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. A thorough biomarker strategy to address key aspects of tumor immunogenicity will be implemented in the study.

LAG525 and spartalizumab are two immuno-agents targeting different immune checkpoints, and have been tested as single agents and in combination. To further enhance the efficacy of checkpoint inhibition, carboplatin will be given with LAG525 or with LAG525 and spartalizumab, based on the observation that the addition of chemotherapy can change the tumor microenvironment to be more favorable to immune response.

Detailed Study Description

The sponsor and the study steering committee decided to prematurely stop enrollment of subjects to Arm 1 after data review showed an increased treatment discontinuation rate due to progressive disease in Arm 1 as compared to Arms 2 and 3 (both containing Carboplatin).

Clinical Study Identifier: NCT03499899

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Novartis Investigative Site

El Metn, Lebanon
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Ashrafieh, Lebanon
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