Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-03 @ 5:12 PM
Study NCT ID:
NCT00357461
Status:
WITHDRAWN
Last Update Posted:
2013-05-15
First Post:
2006-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
Official Title:
A Randomized Phase II Study of Fixed Dose Ipilimumab (MDX-010) 10 mg/kg Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 VG for Previously Treated HLA-A * 0201 Positive Subjects With Stage IV Melanoma
Status:
WITHDRAWN
Status Verified Date:
2013-05
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:
None
Brief Summary:
RATIONALE: Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Vaccines made from gp100 peptides may help the body build an effective immune response to kill tumor cells. Giving ipilimumab together with vaccine therapy may be an effective treatment for melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.
PURPOSE: This randomized phase II trial is studying ipilimumab and vaccine therapy to see how well they work compared to ipilimumab alone in treating patients with previously treated stage IV melanoma.
Detailed Description:
OBJECTIVES:
Primary
* Compare the impact of ipilimumab with vs without gp100 peptides emulsified with Montanide ISA-51 on clinical response in patients with previously treated, HLA-A\*0201 positive stage IV melanoma.
Secondary
* Compare the safety/toxicity profile of these regimens in these patients.
* Determine the immunologic response, as measured by in vitro assays using peripheral blood samples, in patients treated with these regimens.
* Determine the response rate after a re-induction regimen for patients who have relapsed after initial response.
* Determine overall survival.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to ECOG performance status (0 vs 1 or 2) and metastases (M1a vs M1 b or M1c). Patients are randomized to 1 of 2 treatment arms.
* Induction phase:
* Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
* Arm II: Patients receive ipilimumab as in arm I. Patients also receive gp100 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on day 1.
In both arms, treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better for 12 weeks after 4 courses proceed to maintenance phase.
* Maintenance phase:
* Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
* Arm II: Patients receive ipilimumab IV as in arm I and gp100 peptides emulsified in Montanide ISA-51 SC on day 1.
Treatment in both arms begins in approximately week 21 and repeats every 3 months for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who relapse or progress while on maintenance phase undergo re-induction comprising 4 courses of treatment with ipilimumab with or without gp100 peptides emulsified in Montanide ISA-51 as in induction phase. Patients achieving responding disease (complete response, partial response, or stable disease) for 12 weeks after re-induction proceed to the maintenance phase as above for up to 8 courses of treatment.
After completion of study treatment, patients are evaluated for 3 weeks after the last treatment, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.
Primary
* Compare the impact of ipilimumab with vs without gp100 peptides emulsified with Montanide ISA-51 on clinical response in patients with previously treated, HLA-A\*0201 positive stage IV melanoma.
Secondary
* Compare the safety/toxicity profile of these regimens in these patients.
* Determine the immunologic response, as measured by in vitro assays using peripheral blood samples, in patients treated with these regimens.
* Determine the response rate after a re-induction regimen for patients who have relapsed after initial response.
* Determine overall survival.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to ECOG performance status (0 vs 1 or 2) and metastases (M1a vs M1 b or M1c). Patients are randomized to 1 of 2 treatment arms.
* Induction phase:
* Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
* Arm II: Patients receive ipilimumab as in arm I. Patients also receive gp100 peptides emulsified in Montanide ISA-51 subcutaneously (SC) on day 1.
In both arms, treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better for 12 weeks after 4 courses proceed to maintenance phase.
* Maintenance phase:
* Arm I: Patients receive ipilimumab IV over 90 minutes on day 1.
* Arm II: Patients receive ipilimumab IV as in arm I and gp100 peptides emulsified in Montanide ISA-51 SC on day 1.
Treatment in both arms begins in approximately week 21 and repeats every 3 months for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who relapse or progress while on maintenance phase undergo re-induction comprising 4 courses of treatment with ipilimumab with or without gp100 peptides emulsified in Montanide ISA-51 as in induction phase. Patients achieving responding disease (complete response, partial response, or stable disease) for 12 weeks after re-induction proceed to the maintenance phase as above for up to 8 courses of treatment.
After completion of study treatment, patients are evaluated for 3 weeks after the last treatment, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 94 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: