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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026497
Receipt No. R000030362
Scientific Title Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma
Date of disclosure of the study information 2017/03/10
Last modified on 2019/02/27

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Basic information
Public title Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma
Acronym Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma (PENGUIN trial)
Scientific Title Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma
Scientific Title:Acronym Phase I trial of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma (PENGUIN trial)
Region
Japan

Condition
Condition Pediatric malignant solid tumors, Hodgkin lymphoma
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety, efficacy and pharmacokinetics of nivolumab and to determine the recommended dose of nivolumab in pediatric patients with malignant solid tumors or Hodgkin lymphoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Frequency of adverse effects equivalent to dose-limiting toxicity
Key secondary outcomes Pharmacokinetics
Safety
Overall response rate
Progression-free survival
Overall survival

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 Administration of Nivolumab 3 mg/kg every two weeks as an intravenous infusion
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
1 years-old <=
Age-upper limit
24 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients with pediatric malignancy corresponding to any of the followings
a.Patients with defined malignant solid tumors with residual tumors after at least two previous chemotherapy regimens
2)Patients with Hodgkin lymphoma with residual tumors after at least two previous chemotherapy regimensIn patients with malignant solid tumor, either or both of the followings are satisfied
a.One or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable
b.Having tumor infiltration confirmed by bone-marrow examination
3)In patients with Hodgkin lymphoma, the following all conditions are satisfied
a.One or more lesions confirmed by CT or MRI, regardless of measurable or unmeasurable
b.One or more FDG-PET-positive lesions
c.Not having bone-marrow and/or central nerve system infiltration
4)Aged between 1and 18 in cohort 1. Aged between 1 and 24 in cohort 2
5)Performance Status (ECOG) 0, 1, or 2
6)Not having any of the followings: symptomatic brain metastasis, carcinomatous meningitis, or spinal metastasis requiring radiotherapy or surgical intervention
7)Not having any of the followings: pericardial fluid, pleural effusion or ascites requiring treatment
8)No prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody or other treatment related to T cell regulation
9)Not received systemic corticosteroid at a daily dose of more than 10 mg in prednisolone equivalent or immunosuppressant drug within 14 days before registration
10)Not received anti-cancer drug or other study drug within 28 days before registration
11)Not received operation under general anesthesia within 28 days before registration
12)Leaving a certain interval between radiotherapy and registration
13)Adequate organ function in laboratory tests performed within 14 days before registration
14)>= 94% of SpO2 under room air conditions within 14 days before registration
15)Consent to contraception
16)Written informed consent
Key exclusion criteria 1)Active double cancer (except for completely resected basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, intramucosal cancer, superficial bladder cancer, gastrointestinal cancer resected by ESD or EMR, and other cancer free of relapse for more than 5 years)
2)Infection requiring systemic therapy
3)Active gastrointestinal ulceration
4)Current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings (except for inactive scar or fibrosis associated with radiotherapy)
5)Current or previous severe hypersensitive reaction to medicines
6)Currently active or previously chronic or recurrent auto immune disease (except for type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin disorder requiring no systemic therapy, and any auto immune disease expected not to relapse without external factors)
7)HIV antibody-positive, or HTLV-1 antibody-positive, or HBs antigen-positive, or HCV antibody-positive (except for HCV-RNA-negative even if HCV antibody-positive)
8)Though HBs antigen-negative, HBs antibody-positive and/or HBc antibody-positive, and HBV-DNA quantitative test positive
9)Pregnant or breast-feeding women, or women suspected of being pregnant
10)Psychiatric diseases or psychological symptoms interfering with participation in the trial
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chitose Ogawa
Organization National Cancer Center Hospital
Division name Department of Pediatric Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email chitogaw@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumu Arakawa
Organization National Cancer Center Hospital
Division name Department of Pediatric Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email NCCH1606_office@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 国立研究開発法人国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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 01 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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
2017 Year 03 Month 10 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030362

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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