Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut

NCT03068650 | Unknown

• 1 other identifier: CDX110-05
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent GBM

Interventions

rindopepimut BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Celldex Therapeutics: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

rindopepimut

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Last Updated: October 18, 2017

Record last verified: 2017-06