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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000030938 |
Receipt No. | R000035329 |
Scientific Title | A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study |
Date of disclosure of the study information | 2018/01/24 |
Last modified on | 2018/01/24 |
Basic information | ||
Public title | A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study |
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Acronym | Nivolumab re-challenge therapy after VEGF inhibitor therapy. | |
Scientific Title | A phase II study of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer.
Gunma-Ibaraki-Fukushima-Tochigi (GIFT) group study |
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Scientific Title:Acronym | Nivolumab re-challenge therapy after VEGF inhibitor therapy. | |
Region |
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Condition | ||
Condition | Non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Response of Nivolumab re-challenge therapy after VEGF inhibitor therapy in patients with advanced non-small cell lung cancer. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Overall response rate |
Key secondary outcomes | Progression free survival
Over all survival Adverse events Examination of the immunity |
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 |
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Interventions/Control_1 | Nivolumab re-challenge therapy
(3mg/kg, every 2 weeks) |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Stage IIIB,stageIV without any indications for radiotherapy 3)Those who were benefit from anti PD-1 antibody therapy such as CR, PR, SD. 4)ECOG performance status 0-1 5)With one or more measurable disease (RECIST ver.1.1) 6)Aged 20<= 7)Adequate organ function 8)Less than two weeks interval after last VEGF inhibitor therapy 9)Written informed concent |
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Key exclusion criteria | 1)Symptomatic brain metastasis
2)Active infections diseases 3)Serious complications 4)Active concomitant cancers 5)Severe adverse events of Nivolumab 6)Pregnancy, breastfeeding or suspected of being pregnant 7)Those judged to be not suitable by the attending physician |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Luke's International Hospital | ||||||
Division name | Immunotherapy and Cell Therapy Service | ||||||
Zip code | |||||||
Address | 9-1, Akashi-cho, chuoku, Tokyo, Japan. | ||||||
TEL | +81-3-3541-5151 | ||||||
heiyuji@luke.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tochigi Cancer Center | ||||||
Division name | Department of Medical Oncology, | ||||||
Zip code | |||||||
Address | 4-9-13 | ||||||
TEL | +81-28-658-5151 | ||||||
Homepage URL | |||||||
takasai@tochigi-cc.jp |
Sponsor | |
Institute | GIFT group |
Institute | |
Department |
Funding Source | |
Organization | Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035329 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |