Phase I Study of PDR001 in Patients With Advanced Malignancies.

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Spartalizumab

Criteria

Inclusion Criteria:

• Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists

• ECOG Performance Status ≤ 2

Exclusion Criteria:

• Active autoimmune disease

• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

• Prior PD-1- or PD-L1-directed therapy

Other protocol defined inclusion/exclusion may apply.