SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)

Part of paid clinical trials in San Francisco, California.

Sponsor
MimiVax, LLC
Study ID
NCT05163080
Phase
PHASE2
Status
Unknown

Conditions

  • Newly Diagnosed Glioblastoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SurVaxM — BIOLOGICAL
    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).

Study Details

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.

Key Dates

Start date
Nov 18, 2021
Status verified
Feb 2024
Primary completion
Aug 18, 2024
Completion
Aug 18, 2024

Study Design

Enrollment
247 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Peptide Vaccine (SurVaxM) in emulsion with Montanide given together with locally administered Sargramostim plus adjuvant oral Temozolomide
  • Placebo Comparator: Arm B
    Saline-Montanide emulsion with locally administered saline (instead of sargramostim) plus adjuvant oral temozolomide

Primary Outcome Measure

Overall Survival [ Time Frame: 36 Months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94143-
Miami Cancer InstituteMiamiFlorida33176-
Norton Cancer CenterLouisvilleKentucky40241-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Atlantic HealthSummitNew Jersey07960-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
NorthwellNew YorkNew York10075-
NYU Langone HealthNew YorkNew York10016-
Cleveland ClinicClevelandOhio44195-
Texas OncologyAustinTexas78705-
Fred Hutchinson Cancer Center (FHCC)SeattleWashington98109-

Find similar trials in San Francisco, CA

By research site
University of California· San Francisco, CAMiami Cancer Institute· Miami, FLNorton Cancer Center· Louisville, KYDana Farber Cancer Institute· Boston, MAAtlantic Health· Summit, NJRoswell Park Comprehensive Cancer Center· Buffalo, NY

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