A phase 2 study of LAG525 with PDR001 and carboplatin in advanced TNBC
Research type
Research Study
Full title
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
IRAS ID
245709
Contact name
Mark Tuthill
Contact email
Sponsor organisation
Novartis PHarma AG
Eudract number
2017-004865-28
Duration of Study in the UK
1 years, 9 months, 18 days
Research summary
Summary of Research
Triple-negative breast cancer is an aggressive clinical subset of breast cancer. There is a high unmet medical need for new therapeutic approaches to manage advanced triple negative breast cancer. However, triple negative breast cancer has been shown to respond better to immunotherapy than other Advanced Breast Cancer subtypes. Therefore, immunotherapy has gained much interest as an option to treat triple negative breast cancer. The purpose of this study is to determine whether LAG525 and spartalizumab given with or without carboplatin, or LAG525 given in combination with carboplatin is effective and safe for patients with triple negative breast cancer (breast cancer cells tested negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-). The study will include approximately 96 adult patients, as first or second line therapy, in 25 centers worldwide. During the study visits/assessments patients will receive the medication and undergo to physical examinations, collection of blood samples for standard laboratory testing, Urine collection, pregnancy test, eletrocardiogram, cardiac imaging and imaging examination. Patients will remain in the study until disease progression, unaccepted adverse event, death, withdrawal of consent or study is terminated by the sponsor.
Summary of Results
The English lay summary will be posted public ally on Novartis public website https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cadb794d531a447ecbefb08da5b5092d4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637922698856587934%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=x%2BXVPtLnVFHJlwThr1N1wXvpcWmMYLZcB1c4xYeD1A4%3D&reserved=0 one year post global LPLV
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0267
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion