Trial · NCT02455557

SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT02455557, Phase 2, Active not recruiting, Roswell Park Cancer Institute; results first posted 2021-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma. Trials, record NCT02455557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02455557

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT number: NCT02455557
Status: Active not recruiting
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: Roswell Park Cancer Institute
Conditions: Glioblastoma, Gliosarcoma
Interventions: Laboratory Biomarker Analysis, Montanide ISA 51 VG, Sargramostim, SVN53-67/M57-KLH Peptide Vaccine, Temozolomide
First posted: 2015-05-28
Last updated: 2026-10-22
Results first posted: 2021-02-01

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	Date of diagnosis to the date of first observed disease progression or death due to any cause, assessed at 6 months	The 6-month progression-free survival (PFS6) estimated using the Kaplan-Meier methods. PFS6 is defined as the percentage of patients without tumor progression or death from any cause 6 months after the date of diagnosis by biopsy. Corresponding confidence intervals will be computed.
Secondary	Immune Responses to SurVaxM and Predictors of Response	Up to 30 days after completion of study treatment	A series of exploratory analyses will initially take place including individual subject-level profile plots and overall mean plots used to examining the mean structure. Formal statistical examination of longitudinal patterns will be done through the use of a mixed model. Restricted maximum likelihood estimation will be utilized in the model fitting procedures. Once the model is fit, specific linear contrasts based on the estimated model parameters will be constructed and used to test hypotheses concerning between time point comparisons.
Secondary	Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Up to 30 days after completion of study treatment	Toxicities will be summarized using simple frequencies by grade. CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. Results are presented for the number of participants with drug-related Grade 3 or 4 toxicity/adverse event (AE). Grades range from 0 (none) to 5 (death), with Grade 3 and 4 being defined as follows: Grade 0 = No AE; Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Secondary	Overall Survival	Date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years	The median overall survival estimated using the Kaplan-Meier methods. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals will be computed.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	Date of diagnosis to the date of first observed disease progression or death due to any cause, assessed at 6 months	All treated and eligible patients that completed the priming dose	percentage of participants	NUMBER
SECONDARY	Immune Responses to SurVaxM and Predictors of Response	Up to 30 days after completion of study treatment
SECONDARY	Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Up to 30 days after completion of study treatment	All treated and eligible patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	Date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years	All treated and eligible patients that completed priming dose	months	MEDIAN

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Treatment (SurVaxM, Temozolomide)		95	95% Confidence Interval 86 to 98	percentage of participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Treatment (SurVaxM, Temozolomide)	Grade 1	13		Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Treatment (SurVaxM, Temozolomide)	Grade 2	20		Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Treatment (SurVaxM, Temozolomide)	Grade 3	29		Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Treatment (SurVaxM, Temozolomide)	Grade 4	3		Participants
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4	Treatment (SurVaxM, Temozolomide)	Grade 5	1		Participants
Overall Survival	Treatment (SurVaxM, Temozolomide)		25.8	95% Confidence Interval 19.5 to 43.5	months

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (SurVaxM, Temozolomide)	66
Overall Study	COMPLETED	Treatment (SurVaxM, Temozolomide)	64
Overall Study	NOT COMPLETED	Treatment (SurVaxM, Temozolomide)	2

Source ClinicalTrials.gov

Adverse events222

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Treatment (SurVaxM, Temozolomide)	12	66	41
other	Thrombocytopenia	Blood and lymphatic system disorders	Treatment (SurVaxM, Temozolomide)	4	66	7
other	Angina pectoris	Cardiac disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Atrial fibrillation	Cardiac disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Bradycardia	Cardiac disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Tachycardia	Cardiac disorders	Treatment (SurVaxM, Temozolomide)	3	66	9
other	Deafness	Ear and labyrinth disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Excessive cerumen production	Ear and labyrinth disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Hypoacusis	Ear and labyrinth disorders	Treatment (SurVaxM, Temozolomide)	1	66	1
other	Tinnitus	Ear and labyrinth disorders	Treatment (SurVaxM, Temozolomide)	1	66	1

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (SurVaxM, Temozolomide)	36	66
Total, other adverse events	Treatment (SurVaxM, Temozolomide)	65	66
Total, serious adverse events	Treatment (SurVaxM, Temozolomide)	22	66

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36521103	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016056	Roswell Park Cancer Center Support Grant	JOHNSON, CANDACE S	ROSWELL PARK CANCER INSTITUTE CORP	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02455557

GET https://conductscience.org/api/trials/v1/NCT02455557/events?page=2

API reference For AI assistants