Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03068650
Eligibility Criteria:
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
\-
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03068650
Study Brief:
Protocol Section:
NCT03068650