Phase II clinical trial - Sein métastatique triple négatif

CLAG525B2101
Sein métastatique triple négatif
Essai clinique fermé
Public cible
Adulte
A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer.
Description de l'essai

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.