EUCTR2015-000449-21-BE
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 416
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
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. Additionally the following must apply:
- •Group 1: NSCLC
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)
- •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
Outcomes
Primary Outcomes
Not specified
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