Phase I Study of PDR001 in Patients With Advanced Malignancies.

Phase 1

Completed

• Conditions: Advanced Malignancies
• Interventions: Drug: PDR001

• Registration Number: NCT02678260
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Study Start: 2016-02-19
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDR001	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.

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicities (DLTs)	28 days	cycle = 28 days

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)	cycle = 28 days
Duration of response rate (DOR)	up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)	cycle = 28 days
PK parameter: Cmax	Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)	To characterize the PK profile of PDR001; cycle = 28 days
PK parameter: Tmax	Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)	To characterize the PK profile of PDR001; cycle = 28 days
PK parameter: AUC	Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)	To characterize the PK profile of PDR001; cycle = 28 days
Serum concentration vs. time profiles	C1D1, C3D1	Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration
Presence and/or concentration of anti-PDR001 antibodies	Day 1 on from C1 to C6	To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001.
Objective response rate (ORR)	up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)	cycle = 28 days
PK parameter: half-life	Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)	To characterize the PK profile of PDR001; cycle = 28 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kobe-city, Hyogo, Japan