UMIN-CTR Clinical Trial

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 Chitose Middle name Last name Ogawa
Organization	National Cancer Center Hospital
Division name	Department of Pediatric Oncology
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL	03-3542-2511
Email	NCCH1606_office@ml.res.ncc.go.jp

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

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	26
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	Completed
Date of protocol fixation	2017 Year 01 Month 13 Day
Date of IRB	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 03 Day
Last follow-up date	2022 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 03 Month 10 Day
Last modified on	2022 Year 10 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030362