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Clinical Trials List

Protocol NumberCA209-9DW
NCT Number(ClinicalTrials.gov Identfier)NCT04039607

2019-11-30 - 2024-07-31

Phase III

Recruiting9

ICD-10C22.9

Malignant neoplasm of liver, not specified as primary or secondary

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shi-Ming Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jing-Houng Wang Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文聰 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE Division of Gastroenterological Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Hepatocellular Carcinoma

Objectives

Primary  To compare the OS of nivolumab plus ipilimumab versus SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy. Key Secondary  To compare the ORR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab to SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy.  To evaluate DOR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab and SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy.  To compare the cancer-related symptom burden for participants randomized to nivolumab plus ipilimumab or SOC [sorafenib or lenvatinib]).

Test Drug

OPDIVO (nivolumab) Injection 10mg/mLOPDIVO (nivolumab) Injection 10mg/mLYERVOY (ipilimumab) Injection 5mg/mLYERVOY (ipilimumab) Injection 5mg/mL

Active Ingredient

Nivolumab
Nivolumab
Ipilimumab
Ipilimumab

Dosage Form

IVT
IVT
IVT
IVT

Dosage

10mg/ml
10mg/ml
5mg/ml
5mg/ml

Endpoints

Primary Outcome Measures :
Overall Survival (OS) [ Time Frame: Up to 4 years ]

Inclution Criteria

Inclusion Criteria:

Participants must have a diagnosis of HCC based on histological confirmation
Participants must have an advanced HCC
Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
Child-Pugh score 5 or 6
Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

Exclusion Criteria

Exclusion Criteria:

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Prior liver transplant
Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
Active brain metastases or leptomeningeal metastases

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    650 participants

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