UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033039
Receipt number R000037673
Scientific Title Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)
Date of disclosure of the study information 2018/07/01
Last modified on 2018/08/22 07:55:01

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Basic information

Public title

Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)

Acronym

Prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers

Scientific Title

Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)

Scientific Title:Acronym

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

1st name
Middle name
Last name Hirotsugu Uemura

Organization

Kindai University Faculty of Medicine

Division name

Department of Urology

Zip code


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

1st name
Middle name
Last name Ken Toyoda

Organization

Clinical Research Support Center Kyusyu

Division name

Data center

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582 Japan

TEL

092-631-2920

Homepage URL


Email

uro1801@cres-kyushu.or.jp


Sponsor or person

Institute

Kindai University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037673


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name