This study was to characterize the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in
combination with PDR001 to adult patients with solid tumors. The study consists of a dose
escalation (phase 1) to determine the maximum tolerated dose (MTD) or recommended Phase 2
dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose
expansion (phase 2) which characterized treatment of LAG525 in combination with PDR001 at
the MTD or RP2D.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02460224.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Leslie Lewis
Phone: 919-684-6342
This was a Phase 1/2, multi-center, open-label study comprising a Phase 1 dose escalation
part followed by a Phase 2 dose expansion part.
During the Phase 1 dose escalation part patients with any advanced solid tumor received
the study treatment until the MTD was reached or a lower RP2D was established. The study
had the following 3 dose escalation parts: 1) Single-agent LAG525; 2) Single-agent LAG525
in Japanese patients; 3) Combination of LAG525 with PDR001.
Once the RP2D or MTD had been determined in the escalation parts, additional patients
were to be enrolled in the Phase 2 expansion parts in order to assess the preliminary
anti-tumor activity. Phase 2 expansion cohorts testing single-agent LAG525 were not
opened for enrollment based on emerging data including but not limited to preliminary
anti-tumor activity. Phase 2 expansion cohorts for the combination of LAG525 with PDR001
were opened and 5 tumor types were assessed: 1) Non-small cell lung cancer (NSCLC); 2)
Melanoma; 3) Renal cell cancer (RCC); 4) Mesothelioma; 5) Triple negative breast cancer
(TNBC). The efficacy and safety of the combination of LAG525 with PDR001 in these tumor
types was assessed in both the PD-1/PD-L1 pre-treated and naïve settings.
Lead OrganizationNovartis Pharmaceuticals Corporation