UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015845
Receipt number R000018439
Scientific Title A phase II trial of nivolumab in advanced mucosal melanoma
Date of disclosure of the study information 2014/12/04
Last modified on 2017/12/07 00:54:59

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Basic information

Public title

A phase II trial of nivolumab in advanced mucosal melanoma

Acronym

A phase II trial of nivolumab in advanced mucosal melanoma

Scientific Title

A phase II trial of nivolumab in advanced mucosal melanoma

Scientific Title:Acronym

A phase II trial of nivolumab in advanced mucosal melanoma

Region

Japan


Condition

Condition

mucosal melanoma

Classification by specialty

Gastroenterology Hematology and clinical oncology Obstetrics and Gynecology
Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Overall survival, progression free survival, disease control rate, response duration, time to response, best overall response, rate of change in tumor size, immuno-related disease control rate, immuno-related progression free survival, immuno-related response, toxicity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

nivolumab 2mg/kg, triweekly

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) Histologically proven mucosal melanoma
2) Aged 20 years old or more
3) metastatic or advanced disease
4) ECOG PS of 0 or 1
5) No need for previous treatment
6) Need for measurable lesion
7) No previous chest radiotherapy
8) Adequate organ functions
9) Written informed consent

Key exclusion criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) Active infection requiring systemic therapy.
3) Patients with immune suppression.
4) Patients with central nerve system metastases.
5) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
6) Patients received live vaccines.
7) Patients who received anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti CD137 antibody, or anti CTLA-4 antibody.
8) Positive HBs antigen, or positive HCV antibody.
9) Pregnancy, possible pregnancy or breastfeeding.
10) Psychiatric disease.
11) Patients requiring systemic steroid medication.
12) Poorly controlled diabetes mellitus.
13) Severe pulmonary fibrosis or emphysema.
14) Patients whom principle/sub-investigator judged ineligible to participate in this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Ando

Organization

Aichi Cancer Center Hospital

Division name

Department of Clinical Oncology

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan.

TEL

052-762-6111

Email

mandoh@aichi-cc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Motoo Nomura

Organization

Kyoto University

Division name

Department of Therapeutic Oncology

Zip code


Address

54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.

TEL

075-751-3518

Homepage URL


Email

excell@hkg.odn.ne.jp


Sponsor or person

Institute

Aichi Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Aichi Cancer Center Hospital

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


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

愛知県がんセンター中央病院(愛知県)、京都大学(京都府)、倉敷中央病院(岡山県)、静岡県立静岡がんセンター(静岡県)、千葉大学(千葉県)、滋賀医科大学(滋賀県)


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 04 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

Completed

Date of protocol fixation

2014 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 12 Month 04 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018439


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name