CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
ipilimumab +1 morebiological
Likely dose
Ipilimumab 3 mg/kg IV (Part I) or 10 mg/kg IV (Part II) on day 1 of weeks 1, 9, 17, 25, 33, 41, 53; Tyrosinase/gp100/MART-1 peptides 1 mg SC emulsified in 1 mL Montanide ISA 51 VGAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed melanoma, stage III (≥3 positive lymph nodes) or stage IV
  • ✓Completely resected within the past 6 months
  • ✓Mucosal or ocular melanoma allowed
  • ✓HLA-A*0201 positive by DNA allele-specific polymerase chain reaction assay
Key exclusion· 8
  • ✕Prior anti-CTLA-4 monoclonal antibody (MDX-010)
  • ✕Prior gp100, MART-1, or tyrosinase peptide therapy
  • ✕History of inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, or autoimmune ocular disease
  • ✕HIV positive or Hepatitis B surface antigen positive or Hepatitis C antibody positive

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00084656
NCT00084656Phase 2Completed
CompareCT.gov

An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

Bristol-Myers Squibb·interventional·Posted Jun 11, 2004·Updated Apr 14, 2022

In Brief

A Phase 2 clinical trial evaluating ipilimumab and Tyrosinase/gp100/MART-1 Peptides for Intraocular Melanoma and Melanoma (Skin). Completed, enrolled 77 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntraocular Melanoma, Melanoma (Skin)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartMay 31, 2004
Primary CompletionOct 31, 2009
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 22.1 years ago

Interventions

ipilimumabbiological

IV over 90 mins on day 1, wks 1,9,17,25,33,41,53 Dose: 3 mg/kg (Part I), 10 mg/kg (Part II)

Tyrosinase/gp100/MART-1 Peptidesbiological

(All subjects in Part I and HLA-A\*0201 positive subjects only in Part II): SC, day 1 of wks 1,3,5,7,9,11,17, 21,25,33,41,53 Dose: 1 mg peptide emulsified in 1 mL Montanide ISA 51 VG.)