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Clinical Trial Summary

This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research.

Clinical Trial Description

This clinical study is targeted for the patients who harbor KRAS/NRAS mutation or no actionable genetic abnormalities detected using NGS platform and all patients will be treated with PDR001. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 21 days.

Patients will be continued to receive study drug until the end of study unless the patients in disease progression, unacceptable toxicity, withdrawn consent, or by the investigator's judgment.

The progression of the disease in most patients is defined radiographically and determined according to RECIST criteria ver. 1.1. If there are patients those who need to be provided investigational drug beyond predefined end of treatment, additional extended providing of PDR001 needs the mutual agreement of the investigators and Novartis followed by amendment of study protocol and contract.

At the investigator's discretion, patients who have the initial RECIST PD may continue PDR001. At any time, if assessed by the investigator that the patient is no longer benefiting from PDR001, or the patient experiences a second PD by RECIST, then the patient shall come off study medication. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03693326
Study type Interventional
Source Asan Medical Center
Status Recruiting
Phase Phase 2
Start date November 1, 2018
Completion date June 30, 2022

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