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

Protocol: 
AAAP4008
Phase: 
I/II

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

The purpose of this study is to identify the best dose of LAG525 alone or LAG525 with PDR001 that can be safely given to patients with cancer and to evaluate how well LAG525 or LAG525 and PDR001 together might work in treating patients with cancer. LAG525 acts by blocking a protein called LAG-3 and PDR001 acts by blocking a protein called PD-1. Blocking of these proteins may lead to an increased ability of the immune system to fight against tumor cells. This is the first time LAG525 by itself and LAG525 in combination with PDR001 will be studied in humans. There are two parts of this study, Phase I and Phase II. In Phase I, escalating doses of the drug or the combination of drugs are given to small groups of patients to identify the safest dose of the drug or combination of drugs to study further. In the Phase II part, the identified doses from the Phase I part of the study will be tested in patients with specific cancer types.

Are you Eligible? (Inclusion Criteria)

1. Phase I part: Patients with advanced/metastatic solid tumors, with measurable
or nonmeasurable 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.
2. 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 followingtheir last prior therapy.
3. ECOG Performance Status <= 2.
4. 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.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States