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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT02460224
• Date of registration: 09/05/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.
• Scientific title: 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
• Date of first enrolment: June 17, 2015
• Target sample size: 490
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02460224
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Singapore, Spain, Taiwan, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Advanced Solid Tumors

Intervention(s)

Drug: PDR001

Drug: LAG525

Primary Outcome(s)

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(s)

AUC [Time Frame: 30 months]

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

half-life [Time Frame: 30 months]

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

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

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

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

Tmax [Time Frame: 30 months]

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

Cmax [Time Frame: 30 months]

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

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

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

Secondary ID(s)

CLAG525X2101C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors