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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033182
Receipt No. R000037839
Official scientific title of the study A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)
Date of disclosure of the study information 2018/08/10
Last modified on 2018/09/19

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Basic information
Official scientific title of the study A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)
Title of the study (Brief title) TMB-H basket
Region
Japan

Condition
Condition Colorectal cancer, Gastric cancer, Esophageal cancer, Biliary tract cancer, Pancreatic cancer, and Other gastrointestinal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate efficacy and safety of mono therapy with nivolumab in blood TMB-H (Tumor mutation burden-high) patients with unresectable advanced / recurrent gastrointestinal malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate (ORR) determined by RECIST v1.1
Key secondary outcomes 1)Progression-free survival (PFS) determined by RECIST v1.1
2)Duration of response (DoR) determined by RECIST v1.1
3)Disease control rate (DCR) determined by RECIST v1.1
4)Overall survival (OS)
5)Incidences of 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 Monotherapy with Nivolumab
360 mg, every 3 weeks
intravenous administration
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.>=20 years old
2. Histologically confirmed solid tumors with unresectable advanced or recurrent lesion.
3. One of the following types of solid cancers.
I. Colorectal cancer
II. Stomach cancer
III. Esophagus cancer
IV. Biliary tract cancer
V. Pancreatic cancer
VI. Other gastrointestinal cancer
4. Refractory or intolerant to the following treatments.
I. Colorectal cancer: Fluoropyrimidine, oxaliplatin, irinotecan (In case of RAS wild type, refractory or intolerant to cetuximab or panitumumab)
II. Gastric cancer: No previous treatment or refractory or intorelant to standard first line treatment. Patients who are refractory to second-line treatment are not eligible.
III. Esophageal cancer, Biliary tract cancer, Pancreatic cancer, Other gastrointestinal cancers: standard first line treatment
5. TMB-H identified by analysis of blood sample using Guardant360
6. Tumor tissue can be provided for PD-L1 expression analysis
7. At least one measurable lesion as defined by RECIST ver. 1.1
8. ECOG Performance Status is 0 or 1
9. Laboratory test values at baseline satisfy
10. Woman of child-bearing-potential show negative result of pregnancy test.
11. Patients agree on appropriate contraception during and after final administration.
12. Expected to survive more than 12 weeks.
13. Able to give written informed consent.
Key exclusion criteria 1.History of highly sensitive reactions to other antibody formulations.
2.Considered that side effects from previous medication or surgery affect the safety assessment.
3.Complication or a history of chronic or recurrent autoimmune disease.
4. History of another malignancy within 3 years of baseline (BL).
5. Have central nervous system metastasis.
6. Complications or history of interstitial lung disease, pulmonary fibrosis or radiation pneumonitis.
7. Complication of Diverticulitis or symptomatic gastrointestinal ulcer disease.
8. Have pericardial effusion, pleural effusion or ascites requiring sustained treatment.
9. Uncontrolled tumor associated pain.
10. History of transient cerebral ischemic attack or cerebral vascular accident within 180 days of BL.
11. History of thrombosis or thromboembolism.
12. cardiovascular disease.
13. Uncontrollable diabetes mellitus.
14. Have systemic infection requiring treatment.
15. Requires or has a history of transplantation therapy.
16. History of severe allergy.
17. Have bowel obstruction.
18. Received following therapies within 28 days of BL
- systemic adrenocortical hormone or immunosuppressant.
- other unapproved drugs
- adhesions such as pleura or pericardium
- surgical therapy with general anesthesia
- radiation therapy
19. Received following therapies within 14 days of BL
- any antineoplastic agent
- surgical therapy with local or surface anesthesia
20. Received radiopharmaceuticals within 56 days of BL.
21. Either HIV antibody, HBs antigen or HCV antibody test is positive.
22. Pregnant, nursing or suspected pregnancy.
23. Previous therapeutic history for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD 137, anti-CTLA-4 antibody or other T cell regulation.
24. Patient lacking consent ability
Target sample size 70

Research contact person
Name of lead principal investigator Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Email tmb_core@east.ncc.go.jp

Public contact
Name of contact person Yoshiaki Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Address 6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL 04-7133-1111
Homepage URL
Email tmb_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

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東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 20 Day
Anticipated trial start date
2018 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2018 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037839

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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