UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033182 |
|---|---|
| Receipt number | R000037839 |
| Scientific Title | 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 | 2023/07/03 09:54:56 |
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Basic information
Public title
A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)
Acronym
TMB-H basket
Scientific Title
A multicenter phase II study of Nivolumab monotherapy in recurrent and/or metastatic gastrointestinal cancer patients with high Tumor Mutation Burden (TMB-H)
Scientific Title:Acronym
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. Child-Pugh A hepatocellular carcinomar
VII. Small intestine cancer
VIII. Appendiceal cancer
IX. Anal canal cancer
X.Gastroenteropancreatic neuroendocrine. tumor
XI. GIST
XII. Other solid 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. bTMB cohort: TMB score is evalutated 14 mutations/Mb or over by FoundationOne Liquid CDx
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
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
04-7133-1111
tmb_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
04-7133-1111
Homepage URL
tmb_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
National Cancer Center IRB
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irboffice@east.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東病院(千葉県）国立大学法人北海道大学病院(北海道）、国立研究開発法人 国立がん研究センター中央病院（東京都）、がん研究会有明病院（東京都）、愛知県がんセンター 中央病院（愛知県）、独立行政法人国立病院機構大阪医療センター（大阪府）、独立行政法人国立病院機構 四国がんセンター（愛媛県）、独立行政法人国立病院機構九州がんセンター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | 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
70
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
| 2018 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037839
