Phase I Study of PDR001 in Patients With Advanced Malignancies.
Sponsored by Novartis Pharmaceuticals
About this trial
Last updated 7 years ago
Study ID
CPDR001X1101
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 8 years ago
What is this trial about?
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.
What are the participation requirements?
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.