UMIN-CTR Clinical Trial

Public title

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

Acronym

SCOOP study

Scientific Title

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

Scientific Title:Acronym

SCOOP study

Region

Japan

Condition

metastatic colorectal cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

[Phase1b]
To evaluate the safety of BBI608 in combination with pembrolizumab and determine the recommended dosage of BBI608 in combination with pembrolizumab in patients with advanced gastrointestinal cancer not responded to or intolerant of standard chemotherapy.

[Phase2]
To exploratively assess the efficacy and safety of BBI608 in combination with pembrolizumab in patients with metastatic CRC not responded to or intolerant of standard chemotherapy in each cohort.
Cohort A: High frequency of microsatellite instability (MSI-H)
Cohort B: Microsatellite stable (MSS)
[Additional cohort to the Phase II part]
To exploratively assess the efficacy and safety of BBI608 and pembrolizumab in patients with metastatic consensus molecular subtype (CMS) 1 or 4, MMS, CRC not responsive to or intolerant of standard chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Immune-related objective response rate (irORR) determined by their Response Evaluation Criteria In Solid Tumors (irRECIST)
[Additional cohort to the Phase II part]
Objective response rate determined by the RECIST version 1.1

Key secondary outcomes

Immune-related progression free survival (irPFS) rate at Week 12 determined by the irRECIST
Objective response rate determined by the RECIST version 1.1
Progression free survival rate at Week 12 determined by the RECIST version 1.1
PFS
Overall survival
Disease control rate
Incidence of adverse events
Pharmacokinetic parameters
[Additional cohort to the Phase II part]
Immune-related objective response rate
by irRECIST
Progression free survival, Overall Survival, Disease Control Rate
The incidence of adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1 cycle is 21days.
BBI608: Oral administration at a dose of 240mg or 480 mg BID, every day
Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle
The therapy will be repeated until meeting the discontinuation criteria.
[Additional cohort to the Phase II part]
BBI608: Oral administration at a dose of 240 mg BID, every day
Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

For the additional cohort to the Phase II part, screening tests will be performed to identify CMS 1 or 4 and MSS before obtaining informed consent.

Patients, who meet all of the following inclusion criteria and none of the exclusion criteria, are eligible for enrollment in the study.

1. Patients who personally provided written consent to be the subjects of the study
2. Age of 20 years or older on the day of informed consent
3. [Phase Ib] Histologically confirmed gastrointestinal cancer
[Phase II] Histologically confirmed colon or rectal cancer that is adenocarcinoma , and identification of at least the KRAS codon 12 and 13 mutation status determined by RAS gene testing. Confirmation of the MSI status.
[Additional cohort to the Phase II part]
Histologically confirmed colon or rectal cancer that is adenocarcinoma, and identification of RAS mutation status. Identification of CMS 1 or 4 and MSS by screening tests.
4. [Phase Ib] Gastrointestinal cancer not responded to or intolerant of standard chemotherapy
[Phase II]
A history of treatment with one or more regimens of the following standard chemotherapies for metastatic CRC, and being not responded to or tolerated the chemotherapies
[Additional cohort to the Phase II part]
In accordance with Cohort B in the Phase II part.
5. ECOG PS 0 or 1
6. Patients with evaluable lesions (Cohort A in Phase II and Phase Ib) or measurable lesions (Cohort B in Phase II and the additional cohort to the Phase II part) specified in the RECIST version 1.1
7. Patients with adequate organ function based on the following laboratory values measured within 7 days before enrollment
8. Women of childbearing potential who are negative in a pregnancy test within 7 days before enrollment. Both male and female patients who consent to practice appropriate contraception during the study and for 4 months after the discontinuation of the protocol treatment
9. Patients with an expected survival of at least 3 months

Key exclusion criteria

1. Patients who received chemotherapy, molecular-targeted agents and/or palliative radiotherapy within 2 weeks before the start of the protocol treatment or have not recovered from toxicity caused by previous treatment
2. Patients who underwent general anesthesia, surgery requiring hospitalization and extensive radiotherapy within 4 weeks before the start of the protocol treatment or minor surgery such as implantation of a central venous access device within two weeks before the start of the protocol treatment
3. Patients with active central nervous system metastases or carcinomatous meningitis.
4. Pregnant or lactating women
5. Patients who are unable or not willing to take BBI608 capsules every day
6. Patients with gastrointestinal disease markedly interfering with the absorption of oral formulations as judged by the investigator
7. Patients with active autoimmune disease requiring systemic treatment within 2 years before the start of the protocol treatment.
8. Patients with a history or signs of interstitial lung disease or active non-infectious pneumonitis
9. Patients who underwent organ or bone marrow transplantation
10. Patients who received a live vaccine within 30 days before the start of the protocol treatment
11. Patients who participated in another clinical study within 4 weeks before the start of the protocol treatment and used or using an investigational drug or device
12. Patients who previously received immunotherapy with drugs targeting PD-1, PD-L1 and/or PD-L2 or BBI608 therapy, or took part in a clinical study of pembrolizumab or BBI608
13. Patients with uncontrollable complications
14. Patients with a history of other malignancies within 3 years before the start of the protocol treatment.
15. Patients with clinically significant ECG abnormalities
16. Patients with a history of HIV
17. Patients with active hepatitis B or C

Target sample size

95

Name of lead principal investigator

1st name
Middle name
Last name	Takayuki Yoshino

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code

Address

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

TEL

04-7133-1111

Email

scoop_core@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Yasutoshi Kuboki, Akihito Kawazoe

Organization

National Cancer Center Hospital East

Division name

Department of Experimental Therapeutics and GI Oncology

Zip code

Address

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

TEL

04-7133-1111

Homepage URL

Email

scoop_core@east.ncc.go.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

Sumitomo Dainippon Pharma Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Project of Translational and Clinical Research Core Centers

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター東病院（千葉県）
四国がんセンター（愛媛県）
北海道大学病院（北海道）
がん研究有明病院（東京都）
埼玉がんセンター（埼玉県）

Date of disclosure of the study information

2016

Year

09

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2016

Year

07

Month

19

Day

Date of IRB

2016

Year

09

Month

12

Day

Anticipated trial start date

2016

Year

10

Month

31

Day

Last follow-up date

2020

Year

02

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

07

Month

13

Day

Last modified on

2021

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026630