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Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03068650
Expanded Access Status : No longer available
First Posted : March 3, 2017
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Recurrent GBM Biological: rindopepimut

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: rindopepimut
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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:


No Contacts or Locations Provided

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Responsible Party: Celldex Therapeutics Identifier: NCT03068650    
Other Study ID Numbers: CDX110-05
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents