Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma
|First Received Date ICMJE||July 26, 2006|
|Last Updated Date||May 14, 2013|
|Start Date ICMJE||May 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Clinical response [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00357461 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Ipilimumab With or Without Vaccine Therapy in Treating Patients With Previously Treated Stage IV Melanoma|
|Official Title ICMJE||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|
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.
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.
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Melanoma (Skin)|
|Study Arm (s)||Not Provided|
|Publications *||Downey SG, Klapper JA, Smith FO, Yang JC, Sherry RM, Royal RE, Kammula US, Hughes MS, Allen TE, Levy CL, Yellin M, Nichol G, White DE, Steinberg SM, Rosenberg SA. Prognostic Factors Related to Clinical Response in Patients with Metastatic Melanoma Treated by CTL-Associated Antigen-4 Blockade. Clin Cancer Res. 2007 Nov 2; [Epub ahead of print]|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||16 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00357461|
|Other Study ID Numbers ICMJE||CDR0000486705, NCI-06-C-0159, NCI-P6951, MDX-NCI-06-C-0159|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Bristol-Myers Squibb|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||Bristol-Myers Squibb|
|Verification Date||May 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP