Phase I Study of PDR001 in Patients With Advanced Malignancies.

Advanced Malignancies Clinical Trial

Official title:

A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678260
• Other study ID #: CPDR001X1101
• Status: Completed
• Phase: Phase 1
• Start date: February 19, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: June 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Kobe-city	Hyogo
Japan	Novartis Investigative Site	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

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