CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Ipilimumab +1 moredrug
Likely dose
Ipilimumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01119508
NCT01119508Phase 2Completed
CompareCT.gov

Phase II Study of Ipilimumab Plus Temozolomide in Patients With Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted May 7, 2010·Updated Jun 6, 2024

In Brief

A Phase 2 clinical trial evaluating Ipilimumab and Temozolomide for Metastatic Melanoma. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if combining ipilimumab and temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that are related to your immune system.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2010
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.2 years ago

Interventions

Ipilimumabdrug

Induction Phase: 10 mg/kg by vein (IV) over approximately 90 minutes on Day 1 only repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose repeated every 12 weeks.

Temozolomidedrug

Induction Phase, 200 mg/m\^2 by mouth (PO) on Days 1 to 4, repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose delivered on Days 1 to 5, repeated every 4 weeks.