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OpenTrials
Completed

NCT Number: NCT02678260

Phase I Study of PDR001 in Patients With Advanced Malignancies.

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.

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Key information

Conditions

Advanced Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: 28 days

    cycle = 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2016
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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