The purpose of this signal seeking study is to determine whether treatment with PDR001
and LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further
study.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03365791.
Locations matching your search criteria
United States
Maryland
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer InstituteStatus: Active
Name Not Available
This was a phase II, open-label study to determine the efficacy and safety of treatment
with the combination of PDR001+LAG525 across multiple tumor types that are relapsed
and/or refractory to available standard of care therapies. There were 7 tumor cohorts
assessed: 1) Small cell lung cancer, 2) Gastric/esophageal adenocarcinoma, 3) Castration
resistant prostate adenocarcinoma (CRPC), 4) Soft tissue sarcoma, 5) Ovarian
adenocarcinoma, 6) Advanced well-differentiated neuroendocrine tumors and 7) Diffuse
large B cell lymphoma (DLBCL).
Participants were treated with the combination of PDR001 300 mg with LAG525 400 mg once
every 3 weeks (Q3W) via intravenous (i.v.) infusion. Participants received study
treatment for a maximum of 2 years, or until disease progression (assessed by
investigator per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or
the Revised Response Criteria for Malignant Lymphoma criteria (Cheson et al 2007)),
unacceptable toxicity, death or discontinuation from study treatment for any other
reason.
Lead OrganizationNovartis Pharmaceuticals Corporation