GlioblastomaPhase 2ReACTNCT01498328
A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
A Phase 2 study testing Bevacizumab, Rindopepimut (CDX-110) with GM-CSF and KLH in people with Glioblastoma and Small Cell Glioblastoma, run by Celldex Therapeutics at 45 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma
- What is being tested?
- Bevacizumab, Rindopepimut (CDX-110) with GM-CSF and KLH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 45 sitesUnited States
- Study dates
- Dec 2011to 17 May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among other criteria, patients must meet the following conditions to be eligible for the study:
- Age ≥18 years of age.
- Histologic diagnosis of glioblastoma (WHO Grade IV).
- Documented EGFRvlll positive tumor status (central lab confirmation).
- First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma.
- Previous treatment must include surgery, conventional radiation therapy and temozolomide (TMZ).
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- Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy.
- KPS of ≥ 70%.
- If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of dexamethasone or equivalent per day during the week prior to Day 1.
- Evaluable disease in Groups 1 and 2; measurable disease in Group 2C
- Life expectancy > 12 weeks.
- Patients in Group 2 and 2C must have had disease progression while receiving bevacizumab or within 2 months of treatment with bevacizumab.
Who cannot join
- Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Subjects unable to undergo an MRI with contrast.
- History, presence, or suspicion of metastatic disease
- Prior receipt of vaccination against EGFRvIII.
- Any known contraindications to receipt of study drugs, including known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1.
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- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Evidence of recent hemorrhage on screening MRI of the brain
- Evidence of current drug or alcohol abuse.
- Patients in Group 1 must not have received prior treatment with bevacizumab.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Lehigh Valley Hospital-John and Dorothy Morgan Cancer Center
Allentown, Pennsylvania, 18103
Dent Neurologic Institute, 3980 Sheridan Dr, 3rd Flr Clinical Rsch
Amherst, New York, 14226
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Atlanta Cancer Care
Atlanta, Georgia, 30342
University of Colorado, Denver
Aurora, Colorado, 80045
Texas Oncology Midtown
Austin, Texas, 78705
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute and Mass General Hospital
Boston, Massachusetts, 02115
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637-1470
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
The Long Island Brain Tumor Center at Neurology Surgery, P.C.
Commack, New York, 11725
Baylor Research Institute
Dallas, Texas, 75246
The Preston Robert Tisch Brain Tumor Center; Duke University Medical Center
Durham, North Carolina, 27710
New Jersey Neuroscience Institute JFK Medical Center
Edison, New Jersey, 08818
NorthShore University Health System
Evanston, Illinois, 60201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Memorial Cancer Institute
Hollywood, Florida, 33021
UT Health Science Center, Houston Memorial Hermann Hospital, 6400 Fannin Street, #2800
Houston, Texas, 77030
Sparrow Cancer Center
Lansing, Michigan, 48912
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
University of Southern California (USC) Norris Comprehensive Cancer Center
Los Angeles, California, 90089
John Nasseff Neuroscience Institute, Abbott Northwestern Hospital, 800 e. 28th Str. MR
Minneapolis, Minnesota, 55407
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
UC Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868
Orlando Health, Inc.
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Joseph's Hospital and Medical Center / Barrow Neurological Institute
Phoenix, Arizona, 85013
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Legacy Research Institute
Portland, Oregon, 97232
Rhode Island Hospital
Providence, Rhode Island, 02903
University of Rochester Medical Center
Rochester, New York, 14642
Utah Cancer Specialists
Salt Lake City, Utah, 84116
University of California San Francisco
San Francisco, California, 94143
Swedish Neuroscience Research
Seattle, Washington, 98122
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Institute, Stanford University
Stanford, California, 94305
Stony Brook University Hospital
Stony Brook, New York, 11794-8121
Tampa General Hospital
Tampa, Florida, 33606
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
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.
Read the 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.
- Conditions
- Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma
- Being tested
- Bevacizumab, Rindopepimut (CDX-110) with GM-CSF, KLH
- Keywords
- EGFRvIII, Glioblastoma, Rindopepimut, CDX-110, Small cell, Giant cell, Brain Cancer, Brain Tumor, Gliosarcoma, oligodendroglial, radiotherapy, chemoradiation, Tumor, Bevacizumab, Relapsed, Returned, Recurrent, EGFR variant III
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms, Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.
Rindopepimut (CDX-110) with GM-CSFDrug
Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.
KLHDrug
KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.
| Study group | Role | What they receive |
|---|---|---|
| Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut. | Experimental | About half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab. Receives: Drug: Bevacizumab; Drug: Rindopepimut (CDX-110) with GM-CSF |
| Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control | Experimental | About half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab. Receives: Drug: Bevacizumab; Drug: KLH |
| Group 2 and 2C: Refractory to Bevacizumab | Experimental | Patients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab). Receives: Drug: Bevacizumab; Drug: Rindopepimut (CDX-110) with GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Groups 1 and 2: Progression-free survival rate
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).
Measured: 6 months post-Day 1
Group 2C: Objective Response Rate
Evaluate the anti-tumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the objective response rate (ORR) for patients with measurable disease at study entry.
Measured: Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy
Secondary outcomes (3)
Safety and Tolerability
Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical and neurological examinations, adverse events reporting, and Karnofsky performance status
Measured: Until 28 days or initiation of other anti-cancer treatment, whichever is first
Anti-tumor activity
Evaluated by comparing the treatment regimens for anti-tumor activity, including objective response rate, overall progression free survival (PFS), and overall survival (OS) for Groups 1 and 2; and PFS6, overall PFS, and OS for Group 2C.
Measured: During treatment and every 8 weeks through follow up
EGFRvIII-specific immune response
Characterize the EGFRvIII specific immune response to rindopepimut.
Measured: Several times during the first month of treatment and then approximately every 8 weeks until treatment is stopped.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2015
- Study completion17 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498328
- Sponsor's protocol ID
- CDX110-06
- Acronym
- ReACT
- Status last verified
- Apr 2017
- First submitted
- 21 Dec 2011
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Reardon DA, Desjardins A, Vredenburgh JJ, O'Rourke DM, Tran DD, Fink KL, Nabors LB, Li G, Bota DA, Lukas RV, Ashby LS, Duic JP, Mrugala MM, Cruickshank S, Vitale L, He Y, Green JA, Yellin MJ, Turner CD, Keler T, Davis TA, Sampson JH; ReACT trial investigators. Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial. Clin Cancer Res. 2020 Apr 1;26(7):1586-1594. doi: 10.1158/1078-0432.CCR-18-1140. Epub 2020 Feb 7.
PubMed 32034072Gatson 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.
PubMed 26670466
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma
- ClinicalTrials.gov ID
- NCT01498328
- Acronym / sponsor ID
- ReACT / CDX110-06
- Conditions
- Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma
- Keywords
- EGFRvIII, Glioblastoma, Rindopepimut, CDX-110, Small cell, Giant cell, Brain Cancer, Brain Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- 17 May 2016 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut. | Experimental | Drug: Bevacizumab, Drug: Rindopepimut (CDX-110) with GM-CSFAbout half of the patients who have never received treatment with bevacizumab will receive rindopepimut/GM-CSF in a blinded fashion in combination with bevacizumab. |
| Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control | Experimental | Drug: Bevacizumab, Drug: KLHAbout half of the patients who have never received treatment with bevacizumab will receive KLH in a blinded fashion in combination with bevacizumab. |
| Group 2 and 2C: Refractory to Bevacizumab | Experimental | Drug: Bevacizumab, Drug: Rindopepimut (CDX-110) with GM-CSFPatients with progressive disease while currently on or within two months after discontinuing bevacizumab will be administered rindopepimut/GM-CSF while continuing (or restarting if they had stopped bevacizumab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Among other criteria, patients must meet the following conditions to be eligible for the study:
- Age ≥18 years of age.
- Histologic diagnosis of glioblastoma (WHO Grade IV).
- Documented EGFRvlll positive tumor status (central lab confirmation).
- First or second relapse of de novo glioblastoma or first diagnosis or first relapse of secondary glioblastoma.
Key exclusion criteria (10 listed)
- Among other criteria, patients who meet the following conditions are NOT eligible for the study:
- Subjects unable to undergo an MRI with contrast.
- History, presence, or suspicion of metastatic disease
- Prior receipt of vaccination against EGFRvIII.
- Any known contraindications to receipt of study drugs, including known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinA vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period. | Drug | Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut., Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control, Group 2 and 2C: Refractory to Bevacizumab |
| Rindopepimut (CDX-110) with GM-CSFRindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF. | Drug | Group 1a: Bevacizumab Naïve with Bevacizumab + rindopepimut., Group 2 and 2C: Refractory to Bevacizumab |
| KLHKLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH. | Drug | Group 1b: Bevacizumab Naïve with Bevacizumab + KLH control |
Primary outcome
Groups 1 and 2: 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).
Group 2C: Objective Response Rate
Time frame: Every 8 weeks from Day 1 through progression or initiation of other anti-cancer therapy
Evaluate the anti-tumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the objective response rate (ORR) for patients with measurable disease at study entry.
3 secondary outcomes
Safety and Tolerability
Time frame: Until 28 days or initiation of other anti-cancer treatment, whichever is first
Anti-tumor activity
Time frame: During treatment and every 8 weeks through follow up
EGFRvIII-specific immune response
Time frame: Several times during the first month of treatment and then approximately every 8 weeks until treatment is stopped.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 32034072Reardon DA, Desjardins A, Vredenburgh JJ, O'Rourke DM, Tran DD, Fink KL, Nabors LB, Li G, Bota DA, Lukas RV, Ashby LS, Duic JP, Mrugala MM, Cruickshank S, Vitale L, He Y, Green JA, Yellin MJ, Turner CD, Keler T, Davis TA, Sampson JH; ReACT trial investigators. Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial. Clin Cancer Res. 2020 Apr 1;26(7):1586-1594. doi: 10.1158/1078-0432.CCR-18-1140. Epub 2020 Feb 7.
- Derived from this study: PubMed 26670466Gatson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Rindopepimut (CDX-110) with GM-CSF and KLH in people with Glioblastoma and Small Cell Glioblastoma, run by Celldex Therapeutics at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Groups 1 and 2: Progression-free survival rate (time frame: 6 months post-Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01498328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.