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Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide.
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The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A: sitravatinib + tislelizumab | Experimental | sitravatinib once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years) |
|
| Treatment Arm B: Placebo + tislelizumab | Experimental | sitravatinib-matching placebo once daily and tislelizumab once every 6 weeks, for up to 17 cycles (approximately 2 years) |
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| Treatment Arm C:Sitravatinib + Placebo | Experimental | sitravatinib once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years) |
|
| Treatment Arm D: Matching Placebo | Experimental | sitravatinib-matching placebo once daily and tislelizumab-matching placebo once every 6 weeks, for up to 17 cycles (approximately 2 years) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitravatinib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival (RFS) as assessed by the investigator between Arm A and Arm D | RFS is defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma (HCC) as assessed by the investigator, or death from any cause, whichever occurs first. | Up to 2 Years |
| Recurrence-free survival (RFS) as assessed by the investigator between Arm B and Arm D | defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first. | Up to 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Arm A and Arm B: Recurrence-free survival (RFS) | defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first. | Up to 2 Years |
| Arm A and Arm C: Recurrence-free survival (RFS) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Tislelizumab | Drug | Administered intravenously |
|
| sitravatinib-matching placebo | Drug | administered orally |
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| tislelizumab-matching placebo | Drug | administered intravenously |
|
defined as the time from the date of randomization until the date of the first documented occurrence of intrahepatic or extrahepatic hepatocellular carcinoma as assessed by the investigator, or death from any cause, whichever occurs first. |
| Up to 2 Years |
| Arm A and Arm D: overall survival (OS) | defined as the time from the date of randomization until the date of death due to any cause | Up to 5 Years |
| Arm B and Arm D: overall survival (OS) | defined as the time from the date of randomization until the date of death due to any cause | Up to 5 Years |
| Arm A and Arm B: overall survival (OS) | defined as the time from the date of randomization until the date of death due to any cause | Up to 5 Years |
| Arm A and Arm C: overall survival (OS) | defined as the time from the date of randomization until the date of death due to any cause | Up to 5 Years |
| Arm A and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator | defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC | Up to 2 Years |
| Arm B and Arm D: time to extrahepatic spread (EHS) as assessed by the investigator | defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC | Up to 2 Years |
| Arm A and Arm B: time to extrahepatic spread (EHS) as assessed by the investigator | defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC | Up to 2 Years |
| Arm A and Arm C: time to extrahepatic spread (EHS) as assessed by the investigator | defined as the time from the date of randomization until the date of the first documented occurrence of extrahepatic HCC | Up to 2 Years |
| Number of participants with adverse events (AEs) | Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set | Up to 5 Years |
| Participants Reported Outcome as measured at Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its hepatocellular carcinoma cancer module QLQ-HCC18 | Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100 | Up to 2 Years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000611865 | sitravatinib |
| C000707970 | tislelizumab |
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