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

JRCT ID: jRCT2031200442

Registered date:25/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced Hepatocellular Carcinoma
• Date of first enrollment: 04/02/2021
• Target sample size: 24
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Chile,Japan,China,Japan,Colombia,Japan,Czechia,Japan,France,Japan,Hong Kong,Japan,Korea,Japan,Mexico,Japan,New Zealand,Japan,Poland,Japan,Romania,Japan,Russian Federation,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

Arm A: Nivolumab
Arm B: Nivolumab+Relatlimab dose 1
Arm C: Nivolumab+Relatlimab dose 2

Outcome(s)

• Primary Outcome: - ORR assessed by BICR using RECIST v1.1

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: David Perez Callejo
• Secondary ID(s): NCT04567615