Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04442581
Status:
TERMINATED
Last Update Posted:
2023-04-05
First Post:
2020-06-18
Brief Title:
Cabozantinib and Pembrolizumab for the First-Line Treatment of Advanced Liver Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase 2 Trial of Cabozantinib and Pembrolizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well cabozantinib and pembrolizumab work for the first-line treatment of patients with liver cancer who are not eligible for local therapy ie advanced stage Cabozantinib may stop the growth of tumor cells by blocking some cell surface receptors and signaling pathways inside the tumor cells Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer Giving cabozantinib and pembrolizumab together may work better in treating patients with advanced liver cancer compared to cabozantinib or pembrolizumab alone
Detailed Description:
OUTLINE
Patients receive cabozantinib S-malate orally PO once daily QD on days 1-21 and pembrolizumab intravenously IV over 30 minutes on day 1 Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity Disease assessment by imaging will be performed every 9 weeks
Patients receive cabozantinib S-malate orally PO once daily QD on days 1-21 and pembrolizumab intravenously IV over 30 minutes on day 1 Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity Disease assessment by imaging will be performed every 9 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10548 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |
| NCI-2020-03968 | REGISTRY | None | None |