Clinical trial · Interventional
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Procedure | — | UNRESOLVED |
| Brivanib | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brivanib
- interventionNames
- Drug: Brivanib
- Procedure: Best Supportive Care
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Other: Placebo
- Procedure: Best Supportive Care
Primary outcomes (1)
- measure
- To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC
- timeFrame
- computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Histologic or cytologic confirmed diagnosis of HCC * Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy * Patient has failed ≥ 14 days of Sorafenib treatment * Cirrhotic status of Child-Pugh Class A or B with a score of 7 * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2 * Subjects who have a life expectancy of at least 8 weeks * Adequate hematologic, hepatic, and renal function Exclusion Criteria: * women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy * Previous or concurrent cancer that is distinct in primary site * History of active cardiac disease * Thrombotic or embolic events within the past 6 months * Any other hemorrhage/bleeding event \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks * Inability to swallow tablets or untreated malabsorption syndrome * History of human immunodeficiency virus (HIV) infection * Prior use of systemic investigational agents for HCC (except for Sorafenib)
References
Publications (2)
- DERIVEDLencioni R, Montal R, Torres F, Park JW, Decaens T, Raoul JL, Kudo M, Chang C, Rios J, Boige V, Assenat E, Kang YK, Lim HY, Walters I, Llovet JM. Objective response by mRECIST as a predictor and potential surrogate end-point of overall survival in advanced HCC. J Hepatol. 2017 Jun;66(6):1166-1172. doi: 10.1016/j.jhep.2017.01.012. Epub 2017 Jan 26. PMID 28131794
- DERIVEDLlovet JM, Decaens T, Raoul JL, Boucher E, Kudo M, Chang C, Kang YK, Assenat E, Lim HY, Boige V, Mathurin P, Fartoux L, Lin DY, Bruix J, Poon RT, Sherman M, Blanc JF, Finn RS, Tak WY, Chao Y, Ezzeddine R, Liu D, Walters I, Park JW. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J Clin Oncol. 2013 Oct 1;31(28):3509-16. doi: 10.1200/JCO.2012.47.3009. Epub 2013 Aug 26. PMID 23980090