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

Completed · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT02460224

Run by

Novartis Pharmaceuticals

People needed

490

Starts

2015-06-17

Expected to finish

2020-12-31

Last updated by the study team

2022-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center SC LAG X2101C — New York, New York, United States
• Memorial Sloan Kettering Cancer Center SC — New York, New York, United States
• Duke Clinical Research Institute SC — Durham, North Carolina, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Cancer Therapy and Research Center UT Health Science Center CTRC 2 — San Antonio, Texas, United States
• Huntsman Cancer Institute Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Heidelberg, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Fukuoka, Fukuoka, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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