UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026497 |
|---|---|
| Receipt number | 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 | 2022/10/31 12:51:02 |
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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 | 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
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
NCCH1606_office@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030362
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