UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025086
Receipt number R000028849
Scientific Title Predictive and progonstic biomarkers of nivolumab and pembrolizumab treatment in Renal cell and urothelial carcinoma
Date of disclosure of the study information 2016/12/01
Last modified on 2020/06/03 10:07:10

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Basic information

Public title

Predictive and progonstic biomarkers of nivolumab and pembrolizumab treatment in Renal cell and urothelial carcinoma

Acronym

BINIR study

Scientific Title

Predictive and progonstic biomarkers of nivolumab and pembrolizumab treatment in Renal cell and urothelial carcinoma

Scientific Title:Acronym

BINIR study

Region

Japan


Condition

Condition

Renal cell cercinoma
urothelial carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore novel predictive and prognostic biomarkers of immune checkpoint inhibitors treatment for renal cell and urothelial carcinoma

Basic objectives2

Others

Basic objectives -Others

Explore for novel biomarkers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The difference of progression-free survival (PFS) according to serumchemoline levels and T cell receptor (TCR) repertoire

Key secondary outcomes

The relationship between survivals and , regulatory T cells, MDSC, or other chemokines


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with unresectable or metastatic renal cell carcinoma who will be treated with immune checkpoint inhibitorsr and patients with unresectable or metastatic urothelial carcinoma who will be treated with immune checkpoint inhibitorsr will be recruited.

Key exclusion criteria

Patients who are pregnant or have past history of allergy to immune checkpoint inhibitorsr will be excluded.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kouji
Middle name
Last name Izumi

Organization

Kanazawa University

Division name

Department of Integrative Cancer Therapy and Urology

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa, Ishikawa, Japan

TEL

076-265-2393

Email

azuizu2003@yahoo.co.jp


Public contact

Name of contact person

1st name Kouji
Middle name
Last name Izumi

Organization

Kanazawa University

Division name

Department of Integrative Cancer Therapy and Urology

Zip code

920-8641

Address

13-1 Takaramachi, Kanazawa, Ishikawa, Japan

TEL

076-265-2393

Homepage URL


Email

azuizu2003@yahoo.co.jp


Sponsor or person

Institute

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Ethics Committee of Kanazawa University

Address

13-1 Takaramachi, Kanazawa, Japan

Tel

0762652834

Email

rinri@adm.kanazawa-u.ac.jp


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

2016 Year 12 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

Open public recruiting

Date of protocol fixation

2016 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 12 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

Serum CCL2 and other ckemokines, whole blood TCR repertoire, the number of blood Treg and MDSC are measured before nivolumab and pembrolizumab treatment (0 week) and at 3 (pembrolizumab) or 4 (nivolumab) weeks after commencement of treatment. The relationship between survival data including progression-free and overall survival and serum CCL2, other ckemokines, whole blood TCR repertoire, or the number of blood Treg and MDSC will be analyzed.


Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2020 Year 06 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name