CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,783 enrolled
Drug / intervention
MDX-010 (anti-CTLA4) monoclonal antibody +1 moredrug
Likely dose
MDX-010 3 mg/kg IV infusion over 90 minutes every 3 weeks for 4 doses; MDX-1379 gp100 vaccine 2 subcutaneous injections of 2 mL each every 3 weeks for 4 dosesAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed malignant melanoma
  • ✓Measurable unresectable stage III or IV melanoma
  • ✓HLA-A*0201 positive (required for vaccine compatibility)
  • ✓Prior failure, relapse, or intolerance to IL-2, dacarbazine, and/or temozolomide
Key exclusion· 9
  • ✕Prior malignancies unless disease-free for >5 years (exceptions: treated basal/squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ)
  • ✕Ocular melanoma
  • ✕Active, untreated CNS metastases
  • ✕Prior treatment with MDX-010 (anti-CTLA4) antibody

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

Search/NCT00094653
NCT00094653Phase 3Completed
CompareCT.gov

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-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

Bristol-Myers Squibb·interventional·Posted Oct 22, 2004·Updated Jul 11, 2011

In Brief

A Phase 3 clinical trial evaluating MDX-010 (anti-CTLA4) monoclonal antibody and MDX-1379 (gp100) Melanoma Peptide Vaccine for Melanoma and Metastases. Completed, enrolled 1,783 participants across 209 sites in 13 countries.

Detailed 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, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response \[PR/CR\]); 2) failed to demonstrate an objective response (PR/CR); 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma, Metastases
CountriesArgentina, Belgium, Brazil, Canada, Chile, France, Germany, Hungary, Netherlands, South Africa, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 22, 2004
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.7 years ago

Interventions

MDX-010 (anti-CTLA4) monoclonal antibodydrug

3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses

MDX-1379 (gp100) Melanoma Peptide Vaccinebiological

2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses.