臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 25, 2021
Last modified on	Mar. 17, 2023
Trial ID	jRCT2031200442

Scientific Title	A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors
Public Title	A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors (CA224-073)

Contact for Scientific Queries	Name	David Perez Callejo
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	David Perez Callejo
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 25, 2021
Actual date of first enrollment		Feb. 04, 2021
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Must have a diagnosis of hepatocellular carcinoma(HCC)based on histological confirmation - Must have advanced/metastatic HCC - Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted - Must have at least one Response Evaluation Criteria in Solid Tumors(RECIST)v1.1 measurable untreated lesion - Child-Pugh score of 5 or 6 - Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1 for ECOG performance status scale
	Exclusion Criteria	- Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma - Prior organ allograft or allogeneic bone marrow transplantation - No uncontrolled or significant cardiovascular disease - No active known autoimmune disease
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced Hepatocellular Carcinoma
Intervention(s)		Arm A: Nivolumab Arm B: Nivolumab+Relatlimab dose 1 Arm C: Nivolumab+Relatlimab dose 2
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- ORR assessed by BICR using RECIST v1.1
Secondary Outcome(s)		- Incidence of AEs, SAEs, AEs leading to discontinuation, death and clinically significant changes in clinical laboratory results - DCR, DOR, and PFS assessed by BICR and Investigator - ORR asessed by Investigator - OS - Actual dose - BOR assessed by BICR - LAG-3 expression

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Public University Corporation Yokohama City University Medical center Institutional Review Board
Address	4-57 Urafune-cho Minami-ku Yokohama-shi , Kanagawa
Telephone	+81-45-261-5656
E-Mail	u_chiken@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Dec. 14, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04567615
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Argentina/Australia/Brazil/Chile/China/Colombia/Czechia/France/Hong Kong/Korea/Mexico/New Zealand/Poland/Romania/Russian Federation/Singapore/Spain/Taiwan/Turkey

History of Changes

No	Publication date
4	Mar. 17, 2023	(this page)	Changes
3	Feb. 12, 2023	Detail	Changes
2	Aug. 15, 2022	Detail	Changes
1	Mar. 25, 2021	Detail

List of change history