Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084656
Status:
COMPLETED
Last Update Posted:
2022-04-14
First Post:
2004-06-10
Brief Title:
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Extended Dosing Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinasegp100MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2022-04
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:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Vaccines may make the body build an immune response to kill tumor cells Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma
PURPOSE This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma
PURPOSE This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Achieve at least a 40 autoimmune breakthrough event rate as defined by the induction of grade 1 grade 2 or acceptable grade 3 drug-related autoimmune adverse events in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 and peptide vaccine comprising tyrosinase gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51
Secondary
Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen
Determine the time to disease relapse in patients treated with this regimen
Determine the immunologic response in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 of weeks 1 9 17 25 33 41 and 53 and peptide vaccine comprising tyrosinase gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1 3 5 7 9 11 17 21 25 33 41 and 53
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Achieve at least a 40 autoimmune breakthrough event rate as defined by the induction of grade 1 grade 2 or acceptable grade 3 drug-related autoimmune adverse events in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 and peptide vaccine comprising tyrosinase gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51
Secondary
Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen
Determine the time to disease relapse in patients treated with this regimen
Determine the immunologic response in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-010 IV over 90 minutes on day 1 of weeks 1 9 17 25 33 41 and 53 and peptide vaccine comprising tyrosinase gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1 3 5 7 9 11 17 21 25 33 41 and 53
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA076292 | NIH | None | None |
| P30CA014089 | NIH | None | None |
| MCC-15241 | OTHER | None | None |
| MDX010-16 | OTHER | None | None |
| NCI-6446 | OTHER | None | None |
| CA184-016 | OTHER | BMS | httpsreporternihgovquickSearchP30CA014089 |