CompletedPhase 1 / Phase 2NCT02460224

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.

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.

Checked against the public recordLast updated Feb 10, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations24
SponsorNovartis Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Drug: LAG525; Drug: PDR001
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: Phase I part: \- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Phase II part: * Patients with advanced/metastatic solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who have had disease progression following their last prior therapy and fit into one of the following groups: * Group 1: NSCLC * Group 2: Melanoma * Group 3: Renal cancer * Group 4: Mesothelioma * Group 5: TNBC * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy. Exclusion Criteria: * History of severe hypersensitivity reactions to study treatment ingredients or other mAbs * Active, known or suspected autoimmune disease * Active infection requiring systemic antibiotic therapy * HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Patients receiving chronic treatment with systemic steroid therapy, other than replacement-dose corticosteroids in the setting of adrenal insufficiency * Patients receiving systemic treatment with any immunosuppressive medication * Use of live vaccines against infectious disease within 4 weeks of initiation of study treatment * Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. * Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks * History of drug-induced pneumonitis or current pneumonitis.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Columbia University Medical Center SC LAG X2101CNew York, New York
  • Memorial Sloan Kettering Cancer Center SCNew York, New York
  • Duke Clinical Research Institute SCDurham, North Carolina
  • University of Texas MD Anderson Cancer CenterHouston, Texas
  • Cancer Therapy and Research Center UT Health Science Center CTRC 2San Antonio, Texas
  • Huntsman Cancer Institute Huntsman Cancer InstituteSalt Lake City, Utah
  • Novartis Investigative SiteWestmead, New South Wales
  • Novartis Investigative SiteHeidelberg, Victoria
  • Novartis Investigative SiteLeuven
  • Novartis Investigative SiteEdmonton, Alberta
  • Novartis Investigative SiteToronto, Ontario
  • Novartis Investigative SiteLyon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 10, 2022. Always confirm current availability with the study team.

View original record ↗