The main purpose of this study is to determine whether adding SurVaxM to standard-of-care temozolomide chemotherapy is better than temozolomide treatment alone for patients with newly diagnosed glioblastoma. This study is designed to compare the length of survival in patients with newly diagnosed glioblastoma who receive temozolomide plus SurVaxM to that of patients treated with standard-of-care temozolomide plus placebo. This study aims to discover what effects, both good and bad, this combination of drugs may have on you and to see if the study drug (SurVaxM) can create an immune response in your blood that is directed against your cancer cells. This study also aims to determine whether treatment with SurVaxM plus temozolomide improves the survival of glioblastoma patients like yourself compared to treatment with temozolomide alone.
This is a randomized, placebo-controlled study. That means that some patients will receive an active drug (SurVaxM) and some will receive an inactive drug (placebo). Patients who agree to participate will be randomized (chance) to one of two groups. Patients that are randomized by chance to receive SurVaxM will be treated with standard-of-care temozolomide plus an injection under the skin of SurVaxM in Montanide (a milky white substance that helps SurVaxM to be recognized by the patient's immune system). Patients in this group will also receive a second separate injection of a drug called sargramostim that boosts the patient's immune system at the site of the first injection. These injections will be repeated at regular intervals according to a schedule. Patients that are randomized to receive placebo will be treated with standard-of-care temozolomide plus an injection under the skin of saline (salt water) in Montanide (a milky white substance). Patients in this group will also receive a second separate injection of saline to simulate the injection of sargramostim that patient's in the SurVaxM group receive. These injections will be repeated at regular intervals according to a schedule. The treatments in the two groups (SurVaxM and placebo groups) will be completely indistinguishable to patients and their treating doctors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
247
Consists of a synthetic peptide conjugate that stimulates immune responses capable of killing cancer cells that express the survivin molecule. Multiple copies of the multiplied peptide (SVN53-67/M57) are conjugated to Keyhole Limpet Hemocyanin (KLH) yielding a molecule designated as SVN53-67/M57-KLH. The SVN53-67/M57-KLH conjugate (SurVaxM)produces immune responses in mice and humans that are cross-reactive to the wild-type survivin molecule expressed by tumor cells. The survivin peptide in SurVaxM is a defined antigenic peptide comprised of 15 amino acids that encompass multiple epitopes capable of binding human MHC Class I and murine H2-Kb molecules. SurVaxM also contains a core antigenic epitope that has been modified by substitution of methionine for cysteine at amino acid position 57 (i.e., M57).
University of California
San Francisco, California, United States
Miami Cancer Institute
Miami, Florida, United States
Norton Cancer Center
Louisville, Kentucky, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Atlantic Health
Summit, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
Northwell
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Texas Oncology
Austin, Texas, United States
...and 1 more locations
Overall Survival
To compare overall survival (OS) in patients with newly diagnosed glioblastoma between treatment arms A \& B
Time frame: 36 Months
Grade 3 & Grade 4 Toxicities
To tabulate the number and type of Grade 3 \& Grade 4 toxicities, according to the NCI Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5
Time frame: 36 Months
Progression Free Survival Comparison
To compare Progression Free Survival in patients with newly diagnosed glioblastoma between treatment arms A \& B.
Time frame: 36 months
Overall Survival at Specified Time Points
To compare treatment-associated OS at pre-specified time points (OS-15, OS-18, and OS-24) between treatment arms A \& B.
Time frame: 24 months
Progression-Free Survival at specific time points
To compare treatment associated PFS at pre-specified time points (PFS-3, PFS-6, PFS-12) between treatment arms A \& B
Time frame: 12 months
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