UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029636
Receipt number 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 2023/11/02 17:39:54

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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 or person

Institute

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

Institute

Department

Personal name



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

Main results already published

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

2023 Year 11 Month 02 Day



Link to view the page

Value
https://center6.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