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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

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
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

ovartis sponsored Phase 1 study

CompletedPhase 1

ovartis Pharma. K.K.

Updated 10/17/2023