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

ovartis Pharma Services AG0 sites240 target enrollmentFebruary 24, 2017

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent must be obtained prior to any procedures
•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 following their last prior therapy.
•5\. ECOG Performance Status \= 2\.
•6\. Patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at baseline, and during therapy on this study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\. History of severe hypersensitivity reactions to other mAbs
•2\. Active autoimmune disease or a documented history of autoimmune disease within three years prior to screening.
•3\. Active infection requiring systemic antibiotic therapy.
•4\. Known history of HIV infection.
•5\. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•6\. Systemic anti\-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as washout period.
•7\. Phase II only: Prior PD1\- or PD\-L1\-directed therapy with the exception of patients with renal cell cancer will have been previously treated with anti\-PD\-1 or anti\-PD\-L1 inhibitors.
•8\. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
•9\. Presence of \= CTCAE grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if \= CTCAE grade 3\) due to prior cancer therapy.
•Other protocol\-defined exclusion criteria may apply.