An interventional study of LAG525 alone and in combination with PDR001 in patients with advanced malignancies

Phase 1

• Conditions: Solid tumors; MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000449-21-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-16
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 416

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. Additionally the following must apply:
•Group 1: NSCLC
•Group 2: Melanoma
•Group 3: Renal cancer
•Group 4: Mesothelioma
•Group 5: TNBC
•Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 276
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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 (>
10 mg/day prednisone or equivalent) within 7 days of the first dose of
study treatment, other than replacement-dose corticosteroids in the setting of adrenal
insufficiency
•Patients receiving systemic treatment with any immunosupressive
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.
Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified