Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519266
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
PHP in Combination With IPI1NIVO3 Compared to IPI3NIVO1 Only in Patients With Uveal Melanoma Liver Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination With Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients With Uveal Melanoma Liver Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCANDIUM-III
Brief Summary:
Uveal melanoma is the most common primary intraocular malignancy in adults Despite successful control of the primary tumor metastatic disease will develop in approximately 35-50 of the patients within 10 years The liver is the most common site for metastases and about 50 of the patients will have isolated liver metastases These metastases are generally refractory to systemic chemotherapy and the median survival for patients with liver metastases is about 6 months Regardless of treatment the mortality rate is approximately 90 at 2 years with only about 1 of the patients surviving more than 5 years
The primary objective with this study is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion PHP in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only Secondary objectives include further efficacy and safety analysis as well as biomarker discovery
The primary objective with this study is to evaluate progression-free survival in patients with uveal melanoma liver metastases randomized to either percutaneous hepatic perfusion PHP in combination with ipilimumab and nivolumab or ipilimumab and nivolumab only Secondary objectives include further efficacy and safety analysis as well as biomarker discovery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None