UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)
Title of the study (Brief title)	Prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers
Region	Japan

Condition
Condition	renal cell carcinoma urothelial cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Using novel peripheral blood biomarker, make clear that an effective patient of nivolumab or pembrolizumab of local progressive or metastatic renal cell carcinoma and urinary cancer is predictable
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between disease control rate and PBMC biomarker
Key secondary outcomes	ORR Objective Response Rate TTF Time to Treatment Failure PFS Progression Free Survival OS Overall Survival safety and tolerability Comparison of the DCR, ORR PFS OS with non effective patient

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	renal cell carcinoma 1) Impossible of resection or metastatic clear cell RCC 2) The patient that the treatment with VEGFR tyrosine kinase repressor is enforced as previous treatment more than 1 course 3) Patient older than age at agreement acquisition 20 years old 4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided Urothelial cancer 1) Urinary cancer which is impossible of resection after the chemotherapy 2) The patient that treatment with platinum combination chemotherapy is enforced as previous treatment more than 1 course 3) Patient older than age at agreement acquisition 20 years old 4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided
Key exclusion criteria	1)A synchronism overlap cancer or the patient whom a disease-free period has heterochrony overlap cancer within five years *But I do not do Carcinoma in situ (cancer in the epithelium) and the intramucosal carcinoma judged that I was cured by local treatment with the exclusion. 2) The patient whom I am complicated with mental disease or a mind symptom, and it is judged to have difficulty in participation in study 3) The patient who gives it from head to foot of steroids more than four weeks *But I permit it to the steroid within 10 mg/day by prednisolone conversion. 4) in addition, the patient that a study responsibility doctor or an allotment doctor judged the participation in this study to be inappropriate
Target sample size	80

Research contact person
Name of lead principal investigator	Hirotsugu Uemura
Organization	Kindai University Faculty of Medicine
Division name	Department of Urology
Address	377-2 Ohno-higashi, Osaka Sayama-shi, Osaka 589-8511 Japan
TEL	072-366-0221
Email	huemura@med.kindai.ac.jp

Public contact
Name of contact person	Ken Toyoda
Organization	Clinical Research Support Center Kyusyu
Division name	Data center
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582 Japan
TEL	092-631-2920
Homepage URL
Email	uro1801@cres-kyushu.or.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To meet the endpoints, following items should be collected in this study: -PBMC biomarker status in each time points -Information of adverse events, treatment staus, disease progression, and survival

Management information
Registered date	2018 Year 06 Month 18 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037673