Protocol CDX110-04
Research type
Research Study
Full title
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (The “ACT IV” Study)
IRAS ID
128785
Contact name
Kirsten Hopkins
Contact email
Sponsor organisation
Celldex Therapeutics, Inc
Eudract number
2011-006068-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to find out whether adding treatment with rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug called temozolomide helps to shrink brain tumors or prevents brain tumors from growing and helps patients with brain tumors live longer than treatment with temozolomide alone. Temozolomide is a standard treatment for glioblastoma and all patients in this study will be administered temozolomide according to routine practice. The study will also see how treatment affects the patient’s quality of life. Additional studies may be performed to see how the patient’s immune system (the system the patient’s body uses to fight cancer, infections and “foreign bodies”) is reacting to the treatment. The study will also see what side effects there are when injections of rindopepimut are given along with the commonly used temozolomide chemotherapy. Patients assigned to receive temozolomide alone will be given a different compound, Keyhole Limpet Hemocyanin (KLH) as a “control” injection. A control injection is a shot that is given without any expected therapeutic benefit. The purpose of the control is to disguise which treatment the patient is receiving from the patient and the patient’s doctor.KLH is one of the components (or parts) of the rindopepimut vaccine as well.
This is a Phase 3 study. A phase 3 study is a study that is designed to confirm the results seen in earlier studies with the investigational agent. About half of the patients will receive rindopepimut and half will receive KLH. The study treatments will be blinded, which means that neither the patient nor the patient’s study doctor will know whether the patient is receiving rindopepimut or KLH. This kind of study is called a “randomized, double-blind, controlled study,” and it is the best way to determine the effect of rindopepimut on newly diagnosed glioblastoma.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0213
Date of REC Opinion
7 Jun 2013
REC opinion
Further Information Favourable Opinion