Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut

• Conditions: Recurrent GBM

• Registration Number: NCT03068650
• Lead Sponsor: Celldex Therapeutics

Brief 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. Requests for expanded access to rindopepimut in patients with EGFRvlll expressing recurrent glioblastoma will be considered.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified