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Trial record 1 of 5 for:    Rindopepimut
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Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)

Expanded access is currently available for this treatment.
Verified June 2017 by Celldex Therapeutics
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT03068650
First received: February 27, 2017
Last updated: June 13, 2017
Last verified: June 2017
  Purpose
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 Intervention
Recurrent GBM Biological: rindopepimut

Study Type: Expanded Access     What is Expanded Access?
Available for Intermediate-size Population
Official Title: Expanded Access (Compassionate Use) Treatment Protocol Rindopepimut (CDX-110)

Further study details as provided by Celldex Therapeutics:

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.
  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03068650

Contacts
Contact: Celldex Therapeutics (203) 483-3500 compassionateuse@celldex.com

Sponsors and Collaborators
Celldex Therapeutics
  More Information

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT03068650     History of Changes
Other Study ID Numbers: CDX110-05
Study First Received: February 27, 2017
Last Updated: June 13, 2017

ClinicalTrials.gov processed this record on June 23, 2017