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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLAG525 and PDR001

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

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

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How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

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.

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