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

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

ClinicalTrials.gov Identifier: NCT02460224

Novartis Reference Number: CLAG525X2101C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Advanced Solid Tumors
Phase 
Phase 1
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
490 participants
Start date 
Jun 17, 2015
Completion date 
Nov 23, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LAG525
study drug 1
Drug
PDR001
study drug 2

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.

Study Locations

United States
Columbia University Medical Center SC LAG X2101C
-
New York, 10032
New York
United States
Memorial Sloan Kettering Cancer Center SC
-
New York, 10065
New York
United States
Duke Clinical Research Institute SC
-
Durham, 27704
North Carolina
United States
University of Texas MD Anderson Cancer Center
-
Houston, 77030
Texas
United States
Cancer Therapy and Research Center UT Health Science Center CTRC 2
-
San Antonio, 78229
Texas
United States
Huntsman Cancer Institute Huntsman Cancer Institute
-
Salt Lake City, 84112
Utah
United States
Australia
Novartis Investigative Site
-
Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
-
Heidelberg, 3084
Victoria
Australia
Belgium
Novartis Investigative Site
-
Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
-
Edmonton, T6G 1Z2
Alberta
Canada
Novartis Investigative Site
-
Toronto, M5G 2M9
Ontario
Canada
France
Novartis Investigative Site
-
Lyon Cedex, 69373
-
France
Novartis Investigative Site
-
Saint-Herblain Cédex, 44805
-
France
Germany
Novartis Investigative Site
-
Heidelberg, 69120
-
Germany
Novartis Investigative Site
-
Wuerzburg, 97080
-
Germany
Hong Kong
Novartis Investigative Site
-
Hong Kong,
-
Hong Kong
Italy
Novartis Investigative Site
-
Milano, 20133
MI
Italy
Novartis Investigative Site
-
Modena, 41124
MO
Italy
Japan
Novartis Investigative Site
-
Fukuoka-city, 811-1395
Fukuoka
Japan
Singapore
Novartis Investigative Site
-
Singapore, 119228
-
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Spain
Novartis Investigative Site
-
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
-
Madrid, 28009
-
Spain
Taiwan
Novartis Investigative Site
-
Taipei, 10002
-
Taiwan

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