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Clinical Trials List

Protocol NumberCA209-040
NCT Number(ClinicalTrials.gov Identfier)NCT01658878
Completed

2015-05-01 - 2020-04-30

Phase I/II

Terminated3

ICD-10C22.0

Liver cell carcinoma

ICD-10C22

Malignant neoplasm of liver and intrahepatic bile ducts

A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects with or without Chronic Viral Hepatitis.

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator San-Chi Chen 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Terminated

Audit

CRO

Principal Investigator Ming-Mo Hou Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

14 Terminated

Audit

CRO

Principal Investigator Chiun Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Advanced Hepatocellular Carcinoma

Objectives

Primary Objective:  To establish the safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) for nivolumab administered every 14 days to subjects with advanced HCC Secondary Objectives:  To describe the preliminary antitumor activity of nivolumab in subjects with advanced HCC using RECIST 1.1  To characterize the pharmacokinetics (PK) of nivolumab in subjects with advanced HCC  To investigate the immunogenicity of nivolumab in subjects with advanced HCC

Test Drug

Nivolumab (BMS-936558)

Active Ingredient

Nivolumab

Dosage Form

Injection

Dosage

100mg/10ml

Endpoints

Primary Outcome Measures :
1. Safety of nivolumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
2. Tolerability of nivolumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
3. Objective response rate (ORR) for Expansion phase of nivolumab [ Time Frame: Approximately 6 months minimum follow-up ]
4. ORR for Nivolumab vs Sorafenib Cohort [ Time Frame: Approximately 6 months minimum follow-up ]
5. Safety of nivolumab plus ipilimumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
6. Tolerability of nivolumab plus ipilimumab as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
7. ORR for Nivolumab plus Ipilimumab Combination Cohort [ Time Frame: Approximately 6 months minimum follow-up ]
8. ORR for Child-Pugh B Cohort [ Time Frame: Approximately 6 months minimum follow-up ]
9. Safety of nivolumab plus ipilimumab plus cabozantinib as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
10. Tolerability of nivolumab plus ipilimumab plus cabozantinib as evaluated by incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, deaths and clinical laboratory test abnormalities [ Time Frame: 100 days after last dose ]
11. ORR for Nivolumab plus Ipilimumab plus Cabozantinib Combination Cohort [ Time Frame: Approximately 6 months minimum follow-up ]

Inclution Criteria

Inclusion Criteria:
• Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
• Dose Escalation Phase: Child-Pugh score of 7 points or less. Cohort 5: Child-Pugh Class B (B7-B8). For all other cohorts Child-Pugh score of 6 points or less

Exclusion Criteria

Exclusion Criteria:
• History of autoimmune disease
• Any prior or current clinically significant ascites
• Any history of hepatic encephalopathy

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    290 participants

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