CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 490 enrolled
Drug / intervention
LAG525 +1 moredrug
Likely dose
Not stated in 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/NCT02460224
NCT02460224Phase 2Completed
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A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 Administered to Patients With Advanced Malignancies

Novartis Pharmaceuticals·interventional·Posted Jun 2, 2015·Updated Feb 10, 2022

In Brief

A Phase 2 clinical trial evaluating LAG525 and PDR001 for Advanced Solid Tumors. Completed, enrolled 490 participants across 24 sites in 12 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesAustralia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Singapore, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartJun 17, 2015
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 11.1 years ago

Interventions

LAG525drug

LAG525 was administered via intravenous (i.v.) infusion

PDR001drug

PDR001 was administered via i.v. infusion