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COMPLETEDPhase 1NCT02678260

Phase I Study of PDR001 in Patients With Advanced Malignancies.

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.

Lead sponsor: Novartis Pharmaceuticals•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Novartis Pharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 8, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment18

Start dateFeb 2016

Last updatedJun 8, 2018

Condition

Advanced Malignancies

Locations shown

Novartis Investigative Site

Nagoya, Aichi-ken

Novartis Investigative Site

Kashiwa, Chiba

Novartis Investigative Site

Kobe, Hyōgo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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