臨床研究等提出・公開システム

Scientific Title	A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination with Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Public Title	Phase 1/2 study of Relatlimab and Nivolumab in Combination with Bevacizumab in First-line HCC (CA224-106)

Contact for Scientific Queries	Name	Callejo Perez David
	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	Callejo Perez David
	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		July. 15, 2022
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Participants must have histologic confirmation of advanced/metastatic HCC Naive to systemic therapy for advanced/metastatic HCC 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, or mixed cholangiocarcinoma and HCC Prior allogenic stem cell or solid organ transplantation Prior disease history with increased risk of bleeding Uncontrolled or significant cardiovascular disease Participants with an active, known or suspected autoimmune disease.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hepatocellular Carcinoma
Intervention(s)		Arm A: Nivolumab+Relatlimab+Bevacizumab Arm B: Nivolumab+Bevacizumab
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		DLT assessment PFS assessed by BICR
Secondary Outcome(s)		Safety and tolerability PFS, ORR, OS assessed by BICR

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	June. 08, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT05337137
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	Australia/Canada/China/France/Germany/Hongkong/Italia/Korea/Poland/Singapore/Spain/Taiwan/USA

History of Changes

No	Publication date
2	April. 10, 2025	(this page)	Changes
1	July. 14, 2022	Detail

List of change history