Phase I Study of PDR001 in Patients With Advanced Malignancies.

NCT02678260 | Completed Phase 1

• 1 other identifier: CPDR001X1101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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

Keywords

Advanced malignancies; PDR001; Japanese patients; adults

Outcome Measures

Primary Outcomes (1)

• Incidence of dose limiting toxicities (DLTs)

  cycle = 28 days

  28 days

Secondary Outcomes (9)

• PK parameter: AUC

  Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)

• Serum concentration vs. time profiles

  C1D1, C3D1

• Presence and/or concentration of anti-PDR001 antibodies

  Day 1 on from C1 to C6

• Objective response rate (ORR)

  up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)

• Duration of response rate (DOR)

  up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)

Study Arms (1)

PDR001

EXPERIMENTAL

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.

Drug: PDR001

Interventions

PDR001 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.

PDR001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active autoimmune disease
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Prior PD-1- or PD-L1-directed therapy

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0017, Japan

Location

MeSH Terms

Interventions

spartalizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 9, 2016
• Study Start: February 19, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)