UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023148
Receipt number R000026662
Scientific Title A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer
Date of disclosure of the study information 2016/09/01
Last modified on 2023/02/07 13:39:23

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Basic information

Public title

A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer

Acronym

nivolumab following preoperative chemoradiotherapy in patients with resectable rectal cancer (VOLTAGE)

Scientific Title

A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer

Scientific Title:Acronym

nivolumab following preoperative chemoradiotherapy in patients with resectable rectal cancer (VOLTAGE)

Region

Japan


Condition

Condition

Rectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the safety, efficacy, and proof-of-concept (POC) of immune checkpoint inhibitors and surgical treatment as sequential treatment for patients with primary, local recurrence, or resectable lung and liver metastases after preoperative chemoradiotherapy(CRT) using capecitabine.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Pathological complete response (pCR) rate

Key secondary outcomes

- Objective Response rate(ORR)
- Mode of recurrence
- Disease-free survival(DFS)
- Overall survival (OS)
- Adverse event (AE)
- Rate of completing the protocol therapy
Rate of radical resection for patients with primary resectable rectal cancer
- Macroscopic evaluation of the resected specimen of primary rectal cancer
- Intraoperative safety evaluation
- Postoperative safety evaluation


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

After preoperative chemoradiotherapy, nivolumab(240mg) or nivolumab(240mg) plus ipilimumab (3 mg/kg) will be administered, and then radical surgery will be performed.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

-Phase 1b part and the cohort A,D:primary rectal cncer
1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge
2. Clinical stage of T3-4 N-any M0
3. Age of >= 20 to < 80 years

-The cohort B:local recurrence rectal cancer
1. Clinically diagnosed recurrent rectal cancer in the pelvis
2. The tumor is thought to be resectable by the imaging before CRT
3. Age of >= 20 to =< 75 years

-The cohort C:First rectal cncer wirh resectable lung or liver metastases
1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge.
2. Clinical stage of T3-4 N-any M1a
3. Metastatic liver or lung tumors have been diagnosed clinically resectable
4. Age of >= 20 to < 80 years

-Common criteria:
1. ECOG PS of 0 or 1
2. 50.4 Gy of concurrent pre-CRT completed with daily 1,650 mg/m2 of capecitabine
3. CRT-associated AEs will be recovered to grade =< 1 when study treatment starts
4. Sufficient organ functions

Key exclusion criteria

1.Active multiple cancers .
2.Pts with a history of pelvic radiation.
3.Pts with a history of inflammatory bowel disease.
4.Pts with a history of pneumonitis or ILD.
5.Pts with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
6.Pts requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study.
7.Pts with a history of thyroid dysfunction.
8.Pts with a history or finding of cardiovascular risk falling into any of the following:
・left ventricular ejection rate below 50percent EF.
・history or finding of clinically significant, poorly controlled arrhythmia; exception: patients with well-controlled atrial fibrillation for more than 30 days before enrollment may be enrolled.
・history of acute coronary syndrome, coronary angioplasty, or stent placement within 6 months before enrollment.
・history or class II or more severe congestive heart failure according to NYHA .
・treatment-resistant hypertension.SP>140,DBP>90mmHG
・Pts wearing an implantable cardioverter defibrillator or permanent pacemaker.
9.Pts with poorly controlled diabetes mellitus or other diseases possibly interfering with toxicity evaluation.
10.Pts who are positive for any of the following: HIV-1and2 antibody,HTLV-1 antibody, HBs antigen,HCV antibody test.
HBV-DNA above detection sensitivity will be also excluded.
11.Pts who are pregnant or lactating or who may be pregnant.
12.Pts with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study.
13.history of treatment with nivolumab.
14.Pts who are not willing to or incapable of complying with the procedures specified in the protocol.
15.Pts cannot agree ICF.
16.Pts who are determined by the investigator to be unsuitable as a subject for the study.





Target sample size

90


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Yoshino

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code

277-8577

Address

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

TEL

04-7133-1111

Email

voltage_core@east.ncc.go.jp


Public contact

Name of contact person

1st name Yuichiro
Middle name
Last name Tsukada

Organization

National Cancer Center Hospital East

Division name

Division of Colorectal Surgery

Zip code

277-8577

Address

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

TEL

04-7133-1111

Homepage URL


Email

voltage_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

Project of Translational and Clinical Research Core Centers

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board in national cancer centre

Address

6-5-1,Kashiwanoha,Kashiwa,Chiba,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

国立研究開発法人国立がん研究センター東病院(千葉県)
北海道大学病院(北海道)
独立行政法人国立病院機構 大阪医療センター(大阪府)
愛知県がんセンター(愛知県)


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 01 Day


Related information

URL releasing protocol

A Phase Ib/II Study of BBI608 in Combination with Pembrolizumab in Patients with Metastatic Colorect

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

55

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

2016 Year 06 Month 25 Day

Date of IRB

2016 Year 09 Month 07 Day

Anticipated trial start date

2016 Year 09 Month 25 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 07 Month 13 Day

Last modified on

2023 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name