Trial · NCT01480479
Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
NCT01480479, Phase 3, Completed, Celldex Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma. Trials, record NCT01480479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01480479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma
- NCT number
- NCT01480479
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 745 participants, actual
- Lead sponsor
- Celldex Therapeutics
- Conditions
- Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component
- Interventions
- Rindopepimut (CDX-110) with GM-CSF, Temozolomide, KLH
- First posted
- 2011-11-29
- Last updated
- 2018-01-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | During treatment and every three months from end of treatment through end of study or approximately up to 5 years. | The primary efficacy endpoint of Overall Survival is defined as the number of months from randomization to the date of death (whatever the cause), and will be censored for patients who remain alive at completion of the study for patients with a gross total resection (\~n=374). The overall survival of patients will be monitored and compared between the two study arms until the end of the study. |
| Secondary | Progression-free survival | Every 12 weeks from Day 1 through progression or initiation of other anti-cancer therapy | Compare progression-free survival between the two treatment arms |
| Secondary | Safety and Tolerability | Until day 28 of follow up | Safety and tolerability will be measured by comparing the two arms in regards to vital sign measurement, physical and neurological examination, adverse events reporting, ECOG performance status, and EORTC core Quality of Life Questionnaire |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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.
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/NCT01480479
GET https://conductscience.org/api/trials/v1/NCT01480479/registered