Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094653
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2004-10-21
Brief Title:
MDX-010 Antibody MDX-1379 Melanoma Vaccine or MDX-010MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Study Comparing MDX-010 Monotherapy MDX-010 in Combination With a Melanoma Peptide Vaccine and Melanoma Vaccine Monotherapy in HLA-A20201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma
Status:
COMPLETED
Status Verified Date:
2011-06
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 study is to determine the safety and efficacy of MDX-010 ipilimumab BMS-734016 anti-CTLA4 in combination with MDX-1379 gp100 BMS-734019 in patients with previously treated unresectable Stage III or IV melanoma Survival time will be evaluated as well as patient responses and time to disease progression Eligible patients are those who in response to a single regimen containing interleukin-2 IL-2 dacarbazine andor temozolomide have 1 relapsed following an objective response partial responsecomplete response PRCR 2 failed to demonstrate an objective response PRCR or 3 could not tolerate such a regimen due to unacceptable toxicity Patients will be randomized into one of three groups and will receive one of the following treatments MDX-010 alone MDX-1379 alone or MDX-010 in combination with MDX-1379
Detailed Description:
Melanoma accounts for approximately 5 of all skin cancers in the United States but it accounts for about 75 of all skin cancer deaths In 2004 the expected prevalence of melanoma is 627252 with about 119178 of these cases being Stage III or IV metastatic melanoma First line treatments for metastatic melanoma usually IL-2 dacarbazine andor temozolomide are associated with significant toxicities MDX-010 anti-CTLA4 antibodies are designed to keep the immune system running by blocking CTLA-4 from down-regulating T cell activation MDX-1379 is made up of two peptides that are pieces of a bigger melanoma protein gp100 These peptides bind to HLA-A2 which is then recognized by T cells
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA184-002 | OTHER | BMS | None |