Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma

Clinical Research on the efficacy evaluation and the biomarker of nivolumab to an advance malignant melanoma - CREATIVE (CSPOR-melanoma)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016608

Enrollment

200

Registered

2015-02-23

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant melanoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with unresectable malignant melanoma 2)Patients with one or more lesions which can be measured by computed tomography (CT) scan or nuclear magnetic resonance imaging (MRI) according to RECIST guideline ver. 1.1 3)Patients aged 20 years or older who gave informed consent for the study

Exclusion criteria

Exclusion criteria: 1)Patients with comorbid active infection 2)Patients with interstitial lung disease or pulmonary fibrosis 3)Patients who are or may be pregnant 4)Patients who are difficult to treat due to psychosis or psychiatric symptoms 5)Patients judged to be ineligible for the study by an attending physician

Design outcomes

Primary

Measure	Time frame
1)Response rate (RR) by RECIST 2)Overall Survival (OS)	—

Secondary

Measure	Time frame
1)Progression-free Survival (PFS) 2)Response rate by Immune-Related Response Criteria (irRECIST) 3)Information on drug therapies after discontinuation/completion of administration of nivolumab 4)Selection of the factors predictive of treatment response after administration of nivolumab	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Oncology Research (CSPOR)

cspor-melanoma@csp.or.jp03-5287-2636

Outcome results