Trial record 1 of 1 for:
NCT01498328
A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma (ReACT)
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ClinicalTrials.gov Identifier: NCT01498328 |
Recruitment Status
:
Completed
First Posted
: December 23, 2011
Last Update Posted
: April 7, 2017
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Sponsor:
Celldex Therapeutics
Information provided by (Responsible Party):
Celldex Therapeutics
Tracking Information | |||
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First Submitted Date ICMJE | December 21, 2011 | ||
First Posted Date ICMJE | December 23, 2011 | ||
Last Update Posted Date | April 7, 2017 | ||
Study Start Date ICMJE | December 2011 | ||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Progression-free survival rate [ Time Frame: 6 months post-Day 1 ] Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).
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Change History | Complete list of historical versions of study NCT01498328 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma | ||
Official Title ICMJE | A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma | ||
Brief Summary | The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma. | ||
Detailed Description | This Phase II study will enroll patients into three groups. Group 1 are patients who have never been treated with bevacizumab. These patients will be randomly assigned to receive either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for Group 1 will be blinded. Group 2 and Group 2C patients are those who are refractory to bevacizumab (experienced recurrence or progression of glioblastoma while on bevacizumab or within 2 months of discontinuing bevacizumab). These patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be treated until disease progression or intolerance and all patients will be followed for survival. Patients may be treated with other therapies that are not part of the study after discontinuing treatment with the study vaccine. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Gatson NT, Weathers SP, de Groot JF. ReACT Phase II trial: a critical evaluation of the use of rindopepimut plus bevacizumab to treat EGFRvIII-positive recurrent glioblastoma. CNS Oncol. 2016;5(1):11-26. doi: 10.2217/cns.15.38. Epub 2015 Dec 15. Retraction in: CNS Oncol. 2016;5(2):110. Retraction in:CNS Oncol. 2016;5(2):110 |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
127 | ||
Original Estimated Enrollment ICMJE |
95 | ||
Actual Study Completion Date | May 17, 2016 | ||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria: Among other criteria, patients must meet the following conditions to be eligible for the study:
Exclusion Criteria: Among other criteria, patients who meet the following conditions are NOT eligible for the study:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | 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 | NCT01498328 | ||
Other Study ID Numbers ICMJE | CDX110-06 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Celldex Therapeutics | ||
Study Sponsor ICMJE | Celldex Therapeutics | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Celldex Therapeutics | ||
Verification Date | April 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |