Explorative study for biomarker of nivolumab for renal cell carcinoma

JRCT ID: jRCTs051180102

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: renal cell carcinoma
• Date of first enrollment: 17/04/2018
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Nivolumab is administered as 240 mg once daily at 2-week intervals or 480 mg once daily at 4-week intervals by intravenous drip infusion.

Outcome(s)

• Primary Outcome: Best Overall Response

Secondary Outcome

(1)OS
(2)PFS
(3)DSS
(4) AE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors
Patients who have at least one tumorous lesion of 10 mm over in CT/ MRI and evaluated with RECIST ver1.1
Nuetrphils >= 1500 cells/mm3, platelets >= 75000 cells/mm3, hemoglobin >= 9.0 g/dl, AST <= 78IU/l, ALT <= 85IU/l, total bilirubin <= 1.5 mg/dl, serum creatinine <= 2.0 mg/dl
Over 20 years old patients
written informed consent

Exclude criteria

Patients who have been administered immune checkpoint inhibitors including nivolumab in the past
Patients with active infection of bacteria, fungi or viruses
Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured
Patients suffering from other severe acute or chronic diseases
Pregnant women or women who may be pregnant or lactating women
Patients complicated with psychiatric disorders or psychiatric symptoms and judged to be difficult to participate in the study
Patients found to be unacceptable to components of test drugs (or excipients)
For other reasons, patients who judged ineligible for participation in this study by physician

Related Information

• Primary Sponsor: Nakano Yuzo
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.,Bristol-Myers Squibb Company
• Secondary ID(s): UMIN000030400