UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031541
Receipt number R000035941
Scientific Title Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/01 18:08:01

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Basic information

Public title

Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma

Acronym

Biomarker exploratory research for nivolumab in renal cell carcinoma

Scientific Title

Multi-disciplinary research for predictive factors of nivolumab effect on unresectable or metastatic renal cell carcinoma

Scientific Title:Acronym

Biomarker exploratory research for nivolumab in renal cell carcinoma

Region

Japan


Condition

Condition

Unresectable or metastatic renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effective and efficient biomarkers for Nivolumab in patients with unresectable or metastatic renal cell carcinoma

Basic objectives2

Others

Basic objectives -Others

Exploratory research of biomarker

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Progression free survival at 6 months after Nivolumab administration

Key secondary outcomes

Efficacy: Overall survival
Safety: Rate of side effects


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

1)Cases with renal cell carcinoma histologically or pathologically
2)Patients with unresectable or metastatic renal cell carcinoma
3)Adequate organ function.

Key exclusion criteria

1)Patients with known or previous antoimmune disease
2)Patients who are currently administered corticosteroids
3)Patients with prior therapy by antibody or drug, specifically aiming at regulation of T-cell functions
4)Patients with history of serious anaphylaxis induced by the component of this agent
5)Dementia or psychological disorder difficult to participate in this clinical study
6)Patients with severe complications (active gastrointestinal ulceration, ileus, bowel obstruction, and uncontrolled diabetes mellitus, etc.)
7)Patients with HIV antibody-positive, HBs antibody-positive, or HCV antibody-positive
8)Patients with HBs antigen-negative, HBs antibody- or HBc antibody-positive, and HBV-DNA quantitative test-positive
9)Pregnant or breast-feeding women or women suspected of being pregnant
10)Other cases judged inappropriate by the attending

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutake Tsujikawa

Organization

Graduate School of Pharmaceutical Sciences, Osaka University

Division name

Laboratory of Molecular and Cellular Physiology

Zip code


Address

1-6 Yadaoka, Suita, Osaka

TEL

06-6879-8190

Email

tujikawa@phs.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutake Tsujikawa

Organization

Graduate School of Pharmaceutical Sciences, Osaka University

Division name

Laboratory of Molecular and Cellular Physiology

Zip code


Address

1-6 Yadaoka, Suita, Osaka

TEL

06-6879-8190

Homepage URL


Email

tujikawa@phs.osaka-u.ac.jp


Sponsor or person

Institute

Graduate School of Pharmaceutical Sciences
Department of Urology, Graduate School of Medicine
Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ono Pharmaceutical Co., Ltd
Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit organization

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

大阪大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

2017 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Meta-analysis


Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2018 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name