UMIN-CTR Clinical Trial

Basic information
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
Condition	metastatic colorectal cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Sumitomo Dainippon Pharma 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)	Project of Translational and Clinical Research Core Centers

IRB Contact (For public release)
Organization
Address
Tel
Email

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） 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）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 13 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	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
Other related information

Management information
Registered date	2016 Year 07 Month 13 Day
Last modified on	2021 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026630