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: Drug: Rindopepimut (CDX-110) with GM-CSF
Drug: Temozolomide
Drug: KLH

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Rindopepimut/GM-CSF plus Temozolomide	Rindopepimut (CDX-110) with GM-CSF	-
Rindopepimut/GM-CSF plus Temozolomide	Temozolomide	-
KLH plus Temozolomide	Temozolomide	-
KLH plus Temozolomide	KLH	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	During 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

Name	Time	Method
Progression-free survival	Every 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 Tolerability	Until 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

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
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States