Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199901
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2005-09-16
Brief Title:
Study of NY-ESO-1 ISCOMATRIX in Patients With High-risk Resected Melanoma
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
Randomized Double-blind Phase II Trial of NY-ESO-1 ISCOMATRIX Vaccine and ISCOMATRIX Adjuvant Alone in Patients With Resected Stage Ilc Illb lIIc or IV Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to assess whether treatment with NY-ESO-1 ISCOMATRIX vaccine improves outcomes for people with Malignant Melanoma which has been removed but is at high risk of relapse
Detailed Description:
NY-ESO-1 protein is an immune target found in many cancers including melanoma ISCOMATRIX adjuvant enhances immune responses This trial compares NY-ESO-1 ISCOMATRIX vaccine with ISCOMATRIX adjuvant alone to assess whether treatment with NY-ESO-1 ISCOMATRIX vaccine improves outcomes for participants with Malignant Melanoma which has been removed but is at high risk of recurrence
Eligible participants are randomly allocated to a treatment arm Treatment involves four intramuscular into a muscle injections 1 injection every 4 weeks x 3 plus 1 injection at 6 months
Participants are assessed for recurrence of melanoma safety and immune responses by blood test over the 18 month study period Off study their own doctor will follow them for melanoma recurrence and survival
Eligible participants are randomly allocated to a treatment arm Treatment involves four intramuscular into a muscle injections 1 injection every 4 weeks x 3 plus 1 injection at 6 months
Participants are assessed for recurrence of melanoma safety and immune responses by blood test over the 18 month study period Off study their own doctor will follow them for melanoma recurrence and survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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