Phase I/II Study of PDR001 in Patients With Advanced Malignancies

Status Completed

Clinical Trial Summary

The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors. By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.

Clinical Trial Description

This study was designed as a phase I/II, multi-center, open-label study starting with a phase I dose escalation part followed by a phase II part. Although the study had 2 'arms', the phase I part of the study had 5 dosing cohorts and the phase ll part had 5 treatment groups for a total of 10 reporting groups. PDR001 was administered every 2 weeks until patient experienced unacceptable toxicity, progressive disease per immune related Response Criteria (irRC) and/or treatment was discontinued at the discretion of the investigator or the patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02404441
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 27, 2015
Completion date	July 21, 2020

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