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 advancedmalignancies. - NA

OVARTIS FARMA S.P.A.0 sites416 target enrollmentFebruary 1, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: OVARTIS FARMA S.P.A.
Enrollment: 416
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 1, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OVARTIS FARMA S.P.A.

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent must be obtained prior to any procedures. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
•2\. Age \= 18 years
•3\. 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.
•4\. 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:
•i. Disease recurrence or progression during or after no more than one prior platinum doublet\-based chemotherapy regimen for advanced or metastatic disease. Prior maintenance therapy is allowed
•(considered pemetrexed, erlotinib, bevacizumab).
•ii. Patients must have been tested for mutations affecting EGFR and/or ALK. (Patients with a known mutation in one gene need not be tested for the other). Patients with ALK or EGFR\-positive NSCLC must have had recurrent or progressive disease after
•treatment with the corresponding inhibitor and no more than one platinum doublet\-based chemotherapy, in any sequence.
•b. Melanoma:
•i. Patients with BRAF V600 mutation positive disease must have objective evidence of progression of disease after treatment with a BRAF inhibitor alone or in combination with other agents.

Exclusion Criteria

•1\. Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS\-directed therapy (such as radiotherapy or
•surgery), or increasing doses of corticosteroids within the prior 2 weeks. Patients with treated brain metastases should be neurologically stable for at
•least 4 weeks prior to study entry and off steroids for at least 2 weeks before administration of any study treatment.
•2\. History of severe hypersensitivity reactions to study treatment ingredients or other mAbs
•3\. Patient with out\-of\-range laboratory values defined as:
•Creatinine clearance (calculated using Cockcroft\-Gault formula, or measured) \< 40 mL/min
•Total bilirubin \> 1\.5 x ULN, except for patients with Gilbert’s syndrome who are excluded if total bilirubin \> 3\.0 x ULN or direct bilirubin \> 1\.5 x ULN
•Alanine aminotransferase (ALT) \> 3 x ULN
•Aspartate aminotransferase (AST) \> 3 x ULN
•Absolute neutrophil count (ANC) \< 1\.0 x 109/L