NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-153004

Registered date:01/09/2015

A phase III study of ONO-4538(ONO-4538-23)

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedOvarian cancer
Date of first enrollment21/10/2015
Target sample size316
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 : Liposomal doxorubicin INN of the control intervention : Doxorubicin Dosage And administration of the control intervention : Intravenous administration Control intervention name : gemcitabine INN of the control intervention : gemcitabine Dosage And administration of the control intervention : Intravenous administration

Outcome(s)

Primary Outcomeefficacy Overall survival
Secondary Outcomesafety, efficacy Response rate, progression-free survival, disease control rate, QOL, safety, etc.

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderFemale
Include criteria1. Histologically confirmed epithelial ovarian cancers (including fallopian tube and peritoneal cancer) 2. Estimated life expectancy of at least 90 days at the time of informed consent 3. Patients with disease progression or recurrence during platinum-based treatment or less than 6 months after the last dose of a platinum agent
Exclude criteria1. Patients with prior history of severe hypersensitivity to other antibody products 2. Patient with multiple cancers

Related Information

Contact

public contact
Name ONO PHARMACEUTICAL CO.,LTD. Medicine counseling department
Address
Telephone
E-mail clinical_trial@ono.co.jp
Affiliation
scientific contact
Name ONO PHARMACEUTICAL CO.,LTD. Clinical Opreation III
Address 9-11,Nihonbashi-honcho 4-Chome Chuo-ku,Tookyo,Japan
Telephone
E-mail
Affiliation