UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033794
Receipt number R000037955
Scientific Title Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies
Date of disclosure of the study information 2018/09/01
Last modified on 2023/06/16 06:50:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies

Acronym

NIVOMAT study

Scientific Title

Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies

Scientific Title:Acronym

NIVOMAT study

Region

Japan


Condition

Condition

malignant lymphoma, myelodysplastic syndromes

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate safety and potential efficacy of Nivolumab in patients with relapsed/refractory Diffuse large B-cell lymphoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Confirmed objective response rate;ORR

Key secondary outcomes

Progression-free survival;PFS
Overall survival;OS
Duration of response;DoR
time to response
Rate of Adverse Event


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

Nivolumab (240mg/day) is injected intravenously at Day 1. (One cycle is 14 days).

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) Patients with written informed consent.
2) Be >=20 years of age on the day of signing the informed consent.
3) Patients with Follicular lymphoma or Diffuse large B-cell lymphoma or Extranodal NK/T-cell lymphoma nasal type or myelodysplastic syndrome. patients has been confirmed histologically or cytologically.
4) Recurrent or relapsed after the last chemotherapy is completed or refractory or intolerance to the most recent chemotherapy.
MDS patients resistant or intolerant to azacitidine.
5) Have an ECOG performance status of 0 or 1.
6) Have one or more evaluable lesions
-Lymphoma: A CT image or MRI image with a lesion whose major axis exceeds 15 mm (a lesion with a minor axis exceeding 10 mm when the major axis is 11 mm or more and 15 mm or less) has clearly measurable lesions in two orthogonal directions
-MDS: Bone marrow aspiration is possible and the proportion of blasts in bone marrow can be assessed
7) Demonstrated adequate organ function. 8) Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9)Women of childbearing potential agree to use double contraception methods from day of the informed consent through at least after 5 months of final administration. Women agree to not to breast-feed from day of the informed consent through at least after 5 months of final administration.
Men agree to take double contraception from day of first dose through at least after 7 months of final administration.

Key exclusion criteria

1) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy within 2weeks prior to enrollment Received immunotherapy within 28 days prior to enrollment.
2) Patients with therapeutic history of immune checkpoint inhibitor
3) Patients with hypertension that is difficult to control despite taking multiple medications
4) Patients with a history or finding of congestive heart failure of NYHA classification III or higher
5) Patients with acute coronary syndrome, coronary angioplasty, or stent placement, within 6 months prior to enrollment.
6) Patients with grade 3 or higher active infections according to CTCAE v 4.0
7) Patients with complication or previous history of interstitial lung disease with active symptoms or signs
8) Patients with autoimmune disease complications or a history of chronic / recurrent autoimmune disease
9) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment.
10) Have type I diabetes, or have type II diabetes mellitus which cannot be adequately controlled by insulin therapy
11) Have history of organ transplantation or allogeneic hematopoietic stem cell transplantation.
12) Patients with seizure disorder requiring drug treatment
13) Grade 3 or more bleeding was confirmed 4 weeks before enrollment
14) Patients with double cancer
15) Major surgery within 2 weeks
16)Patients with wounds, ulcers, or fractures that have not healed
17) Either HIV antibody, HBs antigen or HCV antibody test is positive.
18) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients
19) Pregnant women, lactating women or possibly pregnant women
20) Patients judged unsuitable to evaluation of Nivolumab or interpretation of the result

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yosuke
Middle name
Last name Minami

Organization

National Cancer Center Hospital East

Division name

Department of Hematology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

NIVOMAT_core@east.ncc.go.jp


Public contact

Name of contact person

1st name Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse
Middle name
Last name Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse

Organization

National Cancer Center Hospital East

Division name

Department of Hematology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL


Email

NIVOMAT_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

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Hospital Institutional Review Board

Address

6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan

Tel

04-7133-1111

Email

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

国立がん研究センター東病院(千葉県)
愛知県がんセンター(愛知県)
東京医科大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 01 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


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

2018 Year 06 Month 26 Day

Date of IRB

2018 Year 08 Month 13 Day

Anticipated trial start date

2018 Year 09 Month 15 Day

Last follow-up date

2022 Year 02 Month 28 Day

Date of closure to data entry

2022 Year 02 Month 28 Day

Date trial data considered complete

2022 Year 05 Month 30 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 17 Day

Last modified on

2023 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037955


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name