Phase I Study of PDR001 in Patients With Advanced Malignancies.

NCT ID: NCT02678260

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-19
• Study Completion Date: 2017-09-01

Brief 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.

Conditions

Advanced Malignancies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PDR001

PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.

Group Type: EXPERIMENTAL

PDR001

Intervention Type: DRUG

PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.

Interventions

PDR001

PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Countries

Japan

Other Identifiers

CPDR001X1101

Identifier Type: -

Identifier Source: org_study_id