Phase 1/2 study of Relatlimab and Nivolumab in Combination with Bevacizumab in First-line HCC

JRCT ID: jRCT2031220213

Registered date:14/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 15/07/2022
• Target sample size: 20
• Countries of recruitment: Australia,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Hongkong,Japan,Italia,Japan,Korea,Japan,Poland,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,USA,Japan
• Study type: Interventional

Intervention(s)

Arm A: Nivolumab+Relatlimab+Bevacizumab
Arm B: Nivolumab+Bevacizumab

Outcome(s)

Primary Outcome

DLT assessment
PFS assessed by BICR

Secondary Outcome

Safety and tolerability
PFS, ORR, OS assessed by BICR

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Callejo Perez David
• Secondary ID(s): NCT05337137