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Clinical Trials List

Protocol NumberCA224-073

NCT Number(ClinicalTrials.gov Identfier)NCT04567615

2020-12-15 - 2025-01-30

Phase II

Recruiting5

ICD-10C22.0

Liver cell carcinoma

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.

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 Ying-Chun Shen Division of Hematology & Oncology

National Taiwan 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

呂嘉偉 Digestive System Department
吳宗翰 Digestive System Department
周宏學 Digestive System Department
Kun-Ming Chan Digestive System Department
Wei-Chen Lee Digestive System Department
吳庭榕 Digestive System Department
Jen-Shi Chen Digestive System Department
王瑜肇 Digestive System Department
Chia-Hsun Hsieh Digestive System Department
吳教恩 Digestive System Department
周宏學未分科

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu Digestive System Department

China Medical University Hospital

Co-Principal Investigator

Hung-Wei Wang Digestive System Department
Hsueh-Chou Lai Digestive System Department
Cheng-Yuan Peng Digestive System Department
Tsung-Yu Tsai Digestive System Department
Po-Heng Chuang Digestive System Department
Wei-Fan Hsu Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Hsiang Huang Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

Rheun-Chuan Lee Digestive System Department
齊振達 Digestive System Department
齊振達未分科
Chien-An Liu Digestive System Department
I-Cheng Lee Digestive System Department
San-Chi Chen Digestive System Department
Pei-Chang Lee Digestive System Department
Yi-Ping Hung Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

Yih-Jyh Lin Digestive System Department
Hsin-Yu Kuo Digestive System Department
邱宏智未分科
姜乃榮未分科
姜乃榕未分科
Chiu Hung Chiu Digestive System Department
邱彥程 Digestive System Department
Liu Yi-Sheng Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Liver Cancer

Objectives

The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor therapy.

Test Drug

Relatlimab (BMS-986016)Nivolumab (BMS-936558)

Active Ingredient

Relatlimab
Nivolumab (BMS-936558)

Dosage Form

Injection

Dosage

10mg/ml
10mg/ml

Endpoints

Overall response rate (ORR) assessed by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Inclution Criteria

1.Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation.
2.Must have advanced/metastatic HCC.
3.Have to be immunotherapy treatment-naive; no prior immunotherapies are permitted.
4.Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion.
5.Child-Pugh score of 5 or 6.
6.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale.

Exclusion Criteria

1.Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma.
2.Prior organ allograft or allogeneic bone marrow transplantation.
3.No uncontrolled or significant cardiovascular disease.
4.No active known autoimmune disease.

The Estimated Number of Participants

Taiwan

28 participants
Global

250 participants