NCT01480479

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 745 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer. All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin. Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

Detailed description

The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide can help improve the life expectancy of patients with newly diagnosed, resected EGFRvIII positive glioblastoma. The duration of participation in this study may be up to 5 years. After you are screened and enrolled in the study, you will be administered temozolomide and either rindopepimut/GM-CSF or KLH until either disease progression or intolerance to the medications. If your tumor progresses while on this study, your doctor may treat you with other therapies that are not part of the study.

Conditions

• Glioblastoma
• Small Cell Glioblastoma
• Giant Cell Glioblastoma
• Gliosarcoma
• Glioblastoma With Oligodendroglial Component

Interventions

Type	Name	Description
DRUG	Rindopepimut (CDX-110) with GM-CSF	Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
DRUG	Temozolomide	150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.
DRUG	KLH	Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2011-11-29
• Last updated: 2018-01-16

Locations

223 sites across 24 countries: United States, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Mexico, Netherlands, New Zealand, Peru, Spain, Switzerland, Taiwan, Thailand, United Kingdom