NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-163212

Registered date:01/04/2016

A Phase II study of ONO-4538(ONO-4538-39)

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studieduterine cervical cancer, uterine corpus cancer, and soft-tissue sarcoma
Date of first enrollment27/6/2016
Target sample size60
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : ONO-4538 INN of the intervention : Nivolumab Dosage And administration of the intervention : Intravenous administration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomeefficacy Response rate
Secondary Outcomesafety, efficacy Overall survival, Progression-free survival, Safety, etc.

Key inclusion & exclusion criteria

Age minimum18
Age maximum
GenderBOTH
Include criteria1. Patients with recurrent or advanced uterine cervical cancer, uterine corpus cancer, and soft-tissue sarcoma 2. Life expectancy of at least 3 months
Exclude criteria1. Patients with history of severe hypersensitivity to other antibody products 2. Patients with multiple primary cancers

Related Information

Contact

public contact
Name ONO PHARMACEUTICAL CO., LTD. Medical Information Center
Address
Telephone
E-mail clinical_trial@ono.co.jp
Affiliation
scientific contact
Name ONO PHARMACEUTICAL CO., LTD. Clinical Operation 1
Address 9-11,Nihonbashi-honcho 4-Chome Chuo-ku,Tokyo,Japan
Telephone
E-mail
Affiliation