CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
LAG525 +2 moredrug
Likely dose
LAG525 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03499899
NCT03499899Phase 2Completed

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

Novartis Pharmaceuticals·interventional·Posted Apr 17, 2018·Updated Jan 30, 2023

In Brief

A Phase 2 clinical trial evaluating LAG525, PDR001, and 1 other intervention for Triple-negative Breast Cancer. Completed, enrolled 88 participants across 33 sites in 17 countries.

Detailed Summary

The main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Canada, France, Germany, Hungary, Israel, Italy, Japan, Lebanon, Singapore, South Korea, Spain, Taiwan, Thailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 17, 2018
Enrollment StartJul 2, 2018
Primary CompletionFeb 27, 2020
Study CompletionNov 24, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.2 years ago

Interventions

LAG525drug

LAG525 was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 400mg every 21 days. For all arms, LAG525 was infused first

PDR001drug

Spartalizumab was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 300mg every 21 days. Spartalizumab was infused after LAG525

Carboplatindrug

Carboplatin was a concentrate for solution for intravenous infusion, came in 100mg/mL and was dosed per area under the curve (AUC) 6 every 21 days. Carboplatin was infused once LAG525 and spartalizumab infusions were completed