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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030533
Receipt No. R000034817
Scientific Title Phase II trial on Programmed death-One inhibitor plus RadioThERapy in patients with Metastatic Mucosal Melanoma
Date of disclosure of the study information 2018/03/01
Last modified on 2018/09/14

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Basic information
Public title Phase II trial on Programmed death-One inhibitor plus RadioThERapy in patients with Metastatic Mucosal Melanoma
Acronym PORTER-M3 trial
Scientific Title Phase II trial on Programmed death-One inhibitor plus RadioThERapy in patients with Metastatic Mucosal Melanoma
Scientific Title:Acronym PORTER-M3 trial
Region
Japan

Condition
Condition Metastatic Mucosal Melanoma
Classification by specialty
Gastroenterology Obsterics and gynecology Dermatology
Oto-rhino-laryngology Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The safety and efficacy of Nivolumab+Radiotheapy for metastatic mucosal melanoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes

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+Radiotherapy
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 disease
4) No previous treatment for metastatic mucosal melanoma
5) ECOG PS of 0 or 1
6) Need for measurable lesion
7) Adequate organ functions
8) 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) The current radiation field do not overlap the previous radiation field.
3) Active infection requiring systemic therapy.
4) Patients with immune suppression.
5) Patients with central nerve system metastases.
6) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
7) Patients received live vaccines.
8) Pregnancy, possible pregnancy or breastfeeding.
9) Psychiatric disease.
10) Patients requiring systemic steroid medication.
11) Severe pulmonary fibrosis or emphysema.
12) 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 Motoo Nomura
Organization Kyoto University
Division name Department of Medical Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3518
Email mnomura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoo Nomura
Organization Kyoto university
Division name Department of Medical Oncology
Zip code
Address 54 Shogoin Kawahara-cho Sakyo-ku Kyoto 606-8507 Japan
TEL 075-751-3518
Homepage URL
Email mnomura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization None
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、がん研究会有明病院、京都大学、神戸市立医療センター中央市民病院、国立がん研究センター中央病院、滋賀医科大学、静岡県立静岡がんセンター、千葉大学

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 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 11 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
2017 Year 12 Month 23 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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