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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028249
Receipt No. R000032327
Scientific Title Efficacy and safety of ONO-4538 for chemo-refractory germ cell tumors: an open-label, multicentre, phase 2 trial
Date of disclosure of the study information 2017/07/18
Last modified on 2019/02/13

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Basic information
Public title Efficacy and safety of ONO-4538 for chemo-refractory germ cell tumors: an open-label, multicentre, phase 2 trial
Acronym Nivolumab for Chemo-refractory germ cell tumors. (NICHE-GCT study )
Scientific Title Efficacy and safety of ONO-4538 for chemo-refractory germ cell tumors: an open-label, multicentre, phase 2 trial
Scientific Title:Acronym Nivolumab for Chemo-refractory germ cell tumors. (NICHE-GCT study )
Region
Japan

Condition
Condition Unresectable advanced germ cell tumors refractory to second-line or further chemotherapy
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To test the response rate of ONO-4538 for advanced germ cell tumors, failed to achieve complete response after chemotherapy and surgery by multicentre, single arm study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate, central review
Key secondary outcomes 1.Objective response rate, assessment by the attending investigator's
2.Disease control rate, DCR
3.Immune-related Disease Control Rate, irDCR
4.Overall Survival, OS
5.Progression Free Survival, PFS
6.Immune-related Progression Free Survival, irPFS
7.Time to Progression,TTP
8.Duration of response
9.Time to response
10.Best overall response, BOR
11.Immune-related best overall response
12.Percent change from baseline in the diameters
13.Evaluation of response according to Japanese Classification of testicular tumor
14.Rate of metastasectomy

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 ONO-4538 240mg will be administered intravenously at 2-weeks intervals. Six weeks will counts as 1cycle of treatment.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed as gonadal or extragonadal germ cell tumor by histological examination or tumor marker profile
2.Patients received platinum based chemotherapy
3.Patients received chemotherapy using 2 or more regimens
4.Patients with no indication of curative surgery
5.Patients having chemo-refractory disease to the last chemotherapy defined by at least one of the following criteria
a)>20% increase of total diameter of target lesions by RECIST guideline v1.1
b)Development of new lesion
c)At least 2 consecutive tumor marker elevation with 1 or more weeks interval
6.Patietns with a life expectancy of at least 12 weeks
7.Patients having measurable target lesion (RECIST guideline v1.1) defined by radiological imaging study within 4 weeks prior to entry
8.ECOG performance status score 0 or 1
9.Patients whose latest laboratory data meet the below criteria within 7 days before registration.
a)Neutrophils >1,000/uL
b)Platelets >100x103uL
c)Hemoglobin>8.0g/dL
d)AST and ALT <3.0-fold the upper limit of normal(ULN)
e)Total bilirubin <2.0-fold the ULN
f)Creatinine <1.5-fold the ULN or creatinine clearance >30mL/min
10.Men must agree to use contraception from the start of study treatment until 7months or more after the last dose of the investigational product.
11.Women of childbearing potential must agree to use contraception from the time of informed consent until 5 months or more after the last dose of the investigationa1 product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
Key exclusion criteria 1.Patients with multiple primary cancers
2.Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product
3.Patients with current or past history of severe hypersensitivity to any other antibody products
4.Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
5.Patients with a current or past history of interstitial lung disease or pulmonary fibrosis
6.Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
7. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment.
8.Patients with intracranial germ cell tumor
9.Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
10.Patients with uncontrollable, tumor-related pain
11.Ptients who have experienced a transient ischemic attack, cerebrovascular accident thrombosis, or thromboembolismwithin 180 days before registration
12. Patients with a history of uncontrollable or significant cardiovascular disease
13. Patients with uncontrollable diabetes mellitus
14.Patients with systemic infections requiring treatment
15.Patients who have received systemic corticosteroids or immunosuppressants
16.Patients who have received antineoplastic drugs
17.Patients who have undergone surgical adhesion of the pleura or pericardium
18.Patients who have undergone surgery under general anesthesia
19.Patiebts who have undergone surgery involving local or topical anesthesia
20.Patients who have received radiotherapy
21.Patients who have received any radiopharmaceuticals
22. Patients who have previously shown AIDS symptoms or with positive test results for any of the following: HIV, HTLV-1 antibody, HBs antigen, or HCV antibody
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Nishiyama
Organization University of Tsukuba Hospital
Division name Dept. of Urology
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3196
Email nishiuro@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Hashimoto
Organization University of Tsukuba, Tsukuba Clinical Research & Development Organization
Division name Clinical Research Service Center
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3326
Homepage URL
Email koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co., LTD.
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 筑波大学附属病院(茨城)University of Tsukuba Hospital, 北海道大学病院(北海道)Hokkaido University Hospital, 神奈川県立がんセンター(神奈川)Kanagawa Cancer Center, 東北大学病院(宮城)Tohoku University Hospital, 大阪国際がんセンター(大阪) Osaka International Cancer Institute, 京都府立医科大学附属病院(京都) University Hospital Kyoto Prefectural University of Medicine, 岡山大学病院(岡山)Okayama University Hospital, 国立がん研究センター中央病院(東京)National Cancer Center Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 18 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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 18 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 07 Month 14 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032327

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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