Phase I Study of PDR001 in Patients With Advanced Malignancies.

• ClinicalTrials.gov Identifier: NCT02678260
• Recruitment Status: Completed
• First Posted: February 9, 2016
• Last Update Posted: June 8, 2018
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Malignancies	Drug: PDR001	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
• Actual Study Start Date: February 19, 2016
• Actual Primary Completion Date: September 1, 2017
• Actual Study Completion Date: September 1, 2017

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 days ]
   cycle = 28 days

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Japan

Novartis Investigative Site

Nagoya, Aichi, Japan, 466-8560

Novartis Investigative Site

Kashiwa, Chiba, Japan, 277-8577

Novartis Investigative Site

Kobe-city, Hyogo, Japan, 650-0017

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02678260
• Other Study ID Numbers: CPDR001X1101
• First Posted: February 9, 2016
• Last Update Posted: June 8, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Advanced malignancies; PDR001; Japanese patients; adults

Additional relevant MeSH terms:

Neoplasms