Recurrent GBMCDX-110NCT03068650
Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut
A study testing rindopepimut in people with Recurrent GBM, run by Celldex Therapeutics.
Trial summary
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent GBM
- What is being tested?
- rindopepimut
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- The patient has histologically confirmed relapsed or recurrent GBM.
- EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay.
- Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate.
- Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day.
- The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
- The patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive rindopepimut vaccine therapy.
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- The patient is surgically sterile or post-menopausal, or, if of child-bearing potential, had a negative serum pregnancy test within the week prior to initiation of rindopepimut and is not nursing.
- Males and females of childbearing potential must agree to practice an effective form of contraception during the time from signing of informed consent through 28 days after the last dose of rindopepimut.
- The patient is able to read and understand, and has signed a patient informed consent form, which outlines the anticipated benefits and risks of treatment with rindopepimut.
Who cannot join
- -
About this study
Official title: Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.
- Conditions
- Recurrent GBM
- Being tested
- rindopepimut
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rindopepimutBiological
Rindopepimut is an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have glioblastoma multiforme (GBM) that expresses an EGFR mutation, called EGFRvIII. Data from, a randomized, controlled phase 2 study in patients with EGFRvIII positive progressive glioblastoma (the ReACT trial) suggested that vaccination with rindopepimut could improve survival. A randomized, controlled phase III study in patients with newly diagnosed EGFRvIII expressing GBM did not show a survival advantage from rindopepimut vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GBMStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celldex Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068650
- Sponsor's protocol ID
- CDX110-05
- Acronym
- CDX-110
- Status last verified
- Jun 2017
- First submitted
- 27 Feb 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)
- ClinicalTrials.gov ID
- NCT03068650
- Acronym / sponsor ID
- CDX-110 / CDX110-05
- Conditions
- Recurrent GBM
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Celldex TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 3 Mar 2017 (actual)
- 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.
Celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient has histologically confirmed relapsed or recurrent GBM.
- EGFRvIII expression in tumor tissue, as assessed by a central laboratory using the Celldex assay.
- Prior or planned therapy must include standard chemoradiation with temozolomide, unless the patient is not a candidate.
- Systemic corticosteroid therapy tapered to less than 4 mg of dexamethasone (or equivalent) per day.
- The patient does not have a known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| rindopepimutRindopepimut is an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have glioblastoma multiforme (GBM) that expresses an EGFR mutation, called EGFRvIII. Data from, a randomized, controlled phase 2 study in patients with EGFRvIII positive progressive glioblastoma (the ReACT trial) suggested that vaccination with rindopepimut could improve survival. A randomized, controlled phase III study in patients with newly diagnosed EGFRvIII expressing GBM did not show a survival advantage from rindopepimut vaccination. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing rindopepimut in people with Recurrent GBM, run by Celldex Therapeutics.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 18 Oct 2017.