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Ipilimumab + Temozolomide in Metastatic Melanoma

NCT01119508 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-06-06

Study results available
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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.

Conditions

Interventions

DRUG

Ipilimumab

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.

DRUG

Temozolomide

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.

Sponsors & Collaborators

Principal Investigators

  • Sapna P. Patel, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119508 on ClinicalTrials.gov