MedPath

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

Phase 3
Completed
Conditions
Glioblastoma
Small Cell Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma
Glioblastoma With Oligodendroglial Component
Interventions
Registration Number
NCT01480479
Lead Sponsor
Celldex Therapeutics
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
745
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Rindopepimut/GM-CSF plus TemozolomideRindopepimut (CDX-110) with GM-CSF-
Rindopepimut/GM-CSF plus TemozolomideTemozolomide-
KLH plus TemozolomideTemozolomide-
KLH plus TemozolomideKLH-
Primary Outcome Measures
NameTimeMethod
Overall SurvivalDuring treatment and every three months from end of treatment through end of study or approximately up to 5 years.

The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (\~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study.

Secondary Outcome Measures
NameTimeMethod
Progression-free survivalEvery 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy

Compare progression-free survival between the two treatment arms

Safety and TolerabilityUntil day 28 of follow up

Safety and tolerability will be measured by comparing the two arms in regards to vital sign measurement, physical and neurological examination, adverse events reporting, ECOG performance status, and EORTC core Quality of Life Questionnaire

Trial Locations

Locations (223)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

🇺🇸

Mobile, Alabama, United States

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

🇺🇸

Phoenix, Arizona, United States

University of Arizona Health Network

🇺🇸

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

City of Hope Cancer Center

🇺🇸

Duarte, California, United States

UC San Diego Moores Cancer Center

🇺🇸

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

🇺🇸

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

🇺🇸

Orange, California, United States

Kaiser Permanente, Redwood City Medical Center

🇺🇸

Redwood City, California, United States

Scroll for more (213 remaining)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.