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

Brief Summary

This study is 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 (I) 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 (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.

Tracking Information
First Received DateMay 9, 2015
Last Changed DateNovember 15, 2017
Start DateJune 17, 2015
Anticipated Primary Completion DateApril 28, 2019
Primary Outcome Measures

Phase I part: Incidence of dose limiting toxicities (DLTs) [Time Frame: 30 months]

Phase II part: Overall response Rate per RECIST V1.1 [Time Frame: 30 months]

Secondary Outcome Measures

AUC [Time Frame: 30 months]

Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodies [Time Frame: 30 months]

Correlation of PD-L1, Lymphocyte activation gene-3 LAG-3 expression [Time Frame: 30 months]

Overall response Rate (ORR) [Time Frame: 30 months]

Expression of IFN-γ immune-related genes by mRNA profiling [Time Frame: 30 months]

Safety incidence of Adverse Events (AEs [Time Frame: 30 months]

Tolerability measured by dose interruptions [Time Frame: 30 months]

Progression free survival (PFS) [Time Frame: 30 months]

Duration of response (DOR) [Time Frame: 30 months]

Disease control rate (DCR) [Time Frame: 30 months]

Safety measuresd by incidence of Serious Adverse Events (SAEs) [Time Frame: 30 months]

Cmax [Time Frame: 30 months]

Tmax [Time Frame: 30 months]

half-life [Time Frame: 30 months]

Tolerability measured by dose reductions [Time Frame: 30 months]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Advanced Solid Tumors
Intervention
  • Drug: LAG525
  • Drug: PDR001
Study Arms / Comparison Groups3 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment515
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Novartis Pharmaceuticals
Email: Novartis.email@novartis.com
Phone: 1-888-669-6682
Eligibility Criteria

Inclusion Criteria:

Phase I part:

- Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by RECIST version 1.1 (refer to Appendix 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.

Administrative Information
NCTIDNCT02460224
Responsible Party,
SponsorNovartis Pharmaceuticals
Verification DateNovember 2017
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