EUCTR2015-000449-21-DEActive, not recruitingPhase 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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 416
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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)
- •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
- •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
- •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.
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