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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029636
Receipt No. R000033843
Scientific Title A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
Date of disclosure of the study information 2017/10/20
Last modified on 2019/10/21

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Basic information
Public title A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
Acronym HN non-SCC_P2_Nivo
Scientific Title A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
Scientific Title:Acronym HN non-SCC_P2_Nivo
Region
Japan

Condition
Condition non-squamous cell carcinoma of the head and neck
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of chemotherapy with Nivolumab for Patients with recurrent or metastatic non-squamous cell carcinoma of the head and neck
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Disease control rate, Overall survival, Progression free survival, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nivolumab 240 mg/body q2weeks
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.Pathologically proven head and neck non squamous cell carcinoma
2.No indication of the local treatment
3.Written informed consent was obtained
4.Aged 20 years or older
5.Platinum resistant/refractory
6.ECOG perfomance status 0-2
7.Life expectancy of at least 3 months
8.Offer of the tumor tissue to use for PD-L1 expression and biomarker analysis
9.One or more measurable lesions
10.Adequate bone marrow, hepatic and renal function
Key exclusion criteria 1.Active concomitant malignancy
2.Active infection
3.Central nervous system metastases
4.Carcinomatous Meningitis
5.Infection of HIV, AIDS related disease, and HCV
6.Medical history of immune checkpoint inhibitor
7.Pregnant, breast-feeding, or unwilling to use adequate contraception
8.Treatment of systemic corticosteroid or other immune suppressor
9.Received radiation therapy within 14 days before registration
10.Histroy of interstitial pneumonia
11.History of auto-immune disease
12.hemodialysis
13.Allergy or hypersensitivity reaction for chemothery or other investigational Products
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naomi Kiyota
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5820
Email nkiyota@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Nagatani
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology / Hematology, Department of Medicine
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5820
Homepage URL
Email nagatani@med.kobe-u.ac.jp

Sponsor
Institute Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
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 京都府立医科大学附属病院(京都府)、近畿大学医学部附属病院(大阪府)、近畿大学医学部奈良病院(奈良県)、奈良県立医科大学附属病院(奈良県)、兵庫県立がんセンター(兵庫県)、宮城県立がんセンター(宮城県)、関西医科大学附属病院(大阪府)、大阪医科大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 20 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 10 Month 23 Day
Date of IRB
2018 Year 01 Month 22 Day
Anticipated trial start date
2018 Year 01 Month 22 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 20 Day
Last modified on
2019 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033843

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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