SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) (SURVIVE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05163080 |
Recruitment Status :
Active, not recruiting
First Posted : December 20, 2021
Last Update Posted : February 26, 2024
|
Tracking Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | December 6, 2021 | |||||||||
First Posted Date ICMJE | December 20, 2021 | |||||||||
Last Update Posted Date | February 26, 2024 | |||||||||
Actual Study Start Date ICMJE | November 18, 2021 | |||||||||
Estimated Primary Completion Date | August 18, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
Overall Survival [ Time Frame: 36 Months ] To compare overall survival (OS) in patients with newly diagnosed glioblastoma between treatment arms A & B
|
|||||||||
Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures |
|
|||||||||
Original Other Pre-specified Outcome Measures | Same as current | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) | |||||||||
Official Title ICMJE | Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE) | |||||||||
Brief Summary | 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. | |||||||||
Detailed Description | 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 ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is a prospective, randomized, placebo-controlled, multi-center study of patients with newly diagnosed Glioblastoma (nGBM)to evaluate a peptide vaccine (SurVaxM) in emulsion with Montanide given together with locally administered sargramostim plus adjuvant oral temozolomide (Arm A) versus saline-Montanide emulsion with locally administered saline (instead of sargramostim) plus adjuvant oral temozolomide (Arm B) Masking: Triple (Participant, Care Provider, Investigator)Masking Description: Double-Blind Primary Purpose: Treatment
|
|||||||||
Condition ICMJE | Newly Diagnosed Glioblastoma | |||||||||
Intervention ICMJE | Biological: SurVaxM
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 Arms ICMJE |
|
|||||||||
Publications * |
|
|||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Active, not recruiting | |||||||||
Estimated Enrollment ICMJE |
247 | |||||||||
Original Estimated Enrollment ICMJE |
265 | |||||||||
Estimated Study Completion Date ICMJE | August 18, 2024 | |||||||||
Estimated Primary Completion Date | August 18, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: To be included in this study, participants must meet the following criteria:
3 .Pathologically confirmed diagnosis of glioblastoma of the cerebrum. 4 .The result of tumor MGMT methylation study must be available. 5 .The result of tumor IDH-1 mutation test must be available. 6. Have the following clinical laboratory values obtained within 14 days prior to registration:
a. gross total resection consisting of no gadolinium enhancement; or b. near-total resection consisting of either ≤ 1 cm3 nodular (i.e. volumetric) enhancement or ≤ 100 mm2 in cross sectional area (i.e. linear enhancement). Note: Patients who undergo either stereotactic biopsy or open biopsy for tissue diagnosis, or partial tumor resection, and who subsequently have a definitive surgical resection may still be eligible for inclusion, provided that randomization can occur within 16 weeks of the date of surgical resection. To be eligible, such patients must still meet postoperative imaging entry criteria as defined in item #8 above. 9. Patients must have completed initial radiation therapy with TMZ (chemoradiation) according to established Stupp protocol (Stupp, 2005) for the treatment of their glioblastoma (i.e., completed 6-week course of RT and completed ≥ 75% of a course of concurrent TMZ chemotherapy). 10. Patients must be randomized within 16 weeks of surgical resection of their newly diagnosed glioblastoma. 11. No evidence of progressive disease at the post-chemoradiation timepoint based on changes in: neurologic exam, corticosteroid use or radiographic progression (i.e., baseline MRI evaluation). (See Section 14.5 for suspected pseudo-progression.) 12. Participants of child-bearing potential (not surgically sterile or postmenopausal) must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and have a negative pregnancy test prior to starting study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 13. Dexamethasone dose less than or equal to 4 mg daily at time of study enrollment. Every reasonable effort should be made to reduce the dose of corticosteroids to the absolute minimum dose required to control neurologic symptoms prior to receiving SurVaxM. 14. Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: Participants with any of the following will be excluded from this study:
|
|||||||||
Sex/Gender ICMJE |
|
|||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT05163080 | |||||||||
Other Study ID Numbers ICMJE | I-813720 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
|
|||||||||
IPD Sharing Statement ICMJE |
|
|||||||||
Current Responsible Party | MimiVax, LLC | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | MimiVax, LLC | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
|
|||||||||
Investigators ICMJE |
|
|||||||||
PRS Account | MimiVax, LLC | |||||||||
Verification Date | February 2024 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |