Unique ID issued by UMIN | UMIN000029636 |
---|---|
Receipt number | R000033843 |
Scientific Title | A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck |
Date of disclosure of the study information | 2017/10/20 |
Last modified on | 2023/11/02 17:39:54 |
A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
HN non-SCC_P2_Nivo
A phase 2 trial of Nivolumab in recurrent or metastatic platinum-refractory non-squamous cell carcinoma of the head and neck
HN non-SCC_P2_Nivo
Japan |
non-squamous cell carcinoma of the head and neck
Hematology and clinical oncology |
Malignancy
YES
To evaluate the efficacy and safety of chemotherapy with Nivolumab for Patients with recurrent or metastatic non-squamous cell carcinoma of the head and neck
Safety,Efficacy
Exploratory
Phase II
Objective response rate
Disease control rate, Overall survival, Progression free survival, Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Nivolumab 240 mg/body q2weeks
20 | years-old | <= |
Not applicable |
Male and Female
1.Pathologically proven head and neck non squamous cell carcinoma
2.No indication of the local treatment
3.Written informed consent was obtained
4.Aged 20 years or older
5.Platinum resistant/refractory
6.ECOG perfomance status 0-2
7.Life expectancy of at least 3 months
8.Offer of the tumor tissue to use for PD-L1 expression and biomarker analysis
9.One or more measurable lesions
10.Adequate bone marrow, hepatic and renal function
1.Active concomitant malignancy
2.Active infection
3.Central nervous system metastases
4.Carcinomatous Meningitis
5.Infection of HIV, AIDS related disease, and HCV
6.Medical history of immune checkpoint inhibitor
7.Pregnant, breast-feeding, or unwilling to use adequate contraception
8.Treatment of systemic corticosteroid or other immune suppressor
9.Received radiation therapy within 14 days before registration
10.Histroy of interstitial pneumonia
11.History of auto-immune disease
12.hemodialysis
13.Allergy or hypersensitivity reaction for chemothery or other investigational Products
24
1st name | |
Middle name | |
Last name | Naomi Kiyota |
Kobe University Hospital and Graduate School of Medicine
Medical Oncology / Hematology, Department of Medicine
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
078-382-5820
nkiyota@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshiaki Nagatani |
Kobe University Hospital and Graduate School of Medicine
Medical Oncology / Hematology, Department of Medicine
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
078-382-5820
nagatani@med.kobe-u.ac.jp
Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Medical Oncology / Hematology, Department of Medicine Kobe University Hospital and Graduate School of Medicine
Self funding
NO
京都府立医科大学附属病院(京都府)、近畿大学医学部附属病院(大阪府)、近畿大学医学部奈良病院(奈良県)、奈良県立医科大学附属病院(奈良県)、兵庫県立がんセンター(兵庫県)、宮城県立がんセンター(宮城県)、関西医科大学附属病院(大阪府)、大阪医科大学附属病院(大阪府)
2017 | Year | 10 | Month | 20 | Day |
Unpublished
Main results already published
2017 | Year | 10 | Month | 23 | Day |
2018 | Year | 01 | Month | 22 | Day |
2018 | Year | 01 | Month | 22 | Day |
2024 | Year | 03 | Month | 31 | Day |
2017 | Year | 10 | Month | 20 | Day |
2023 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033843
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |