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A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

Phase 2
18 Years
Open (Enrolling)
Glioblastoma, Small Cell Glioblastoma, Giant Cell Glioblastoma, Gliosarcoma, Glioblastoma With Oligodendroglial Component, Recurrent Glioblastoma, Relapsed Glioblastoma

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Trial Information

A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

This Phase II study will enroll patients into two groups. Group 1 are patients who have
never been treated with bevacizumab. These patients will be randomly assigned to receive
either rindopepimut/GM-CSF or KLH, each along with bevacizumab. Treatment assignment for
Group 1 will be blinded. Group 2 patients are those who are refractory to bevacizumab
(experienced recurrence or progression of glioblastoma while on bevacizumab). These
patients will all receive rindopepimut/GM-CSF along with bevacizumab. Patients will be
treated until disease progression or intolerance and all patients will be followed for
survival. Patients may be treated with other therapies that are not part of the study
after discontinuing treatment with the study vaccine.

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the

1. Age ≥18 years of age.

2. Histologic diagnosis of glioblastoma (WHO Grade IV).

3. Previous treatment for glioblastoma must include surgery,conventional radiation
therapy and temozolomide (TMZ).

4. First or second relapse of de novo glioblastoma.

5. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at
least 12 weeks after radiation therapy.

6. KPS of ≥ 70%.

7. Life expectancy > 12 weeks.

8. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory.

9. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of
dexamethasone or equivalent per day during the week prior to Day 1.

10. Evaluable disease

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the

1. Subjects unable to undergo an MRI with contrast.

2. History, presence, or suspicion of metastatic disease

3. Prior receipt of vaccination against EGFRvIII.

4. Any known contraindications to receipt of study drugs, including known allergy or
hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®),
polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to
shellfish proteins.

5. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use
of antibody-based investigational therapy within 28 days prior to Day 1.

6. Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment

7. Evidence of recent hemorrhage on screening MRI of the brain

8. Evidence of current drug or alcohol abuse.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate

Outcome Description:

Evaluate the antitumor activity of rindopepimut in adult patients with relapsed glioblastoma, as measured by the progression-free survival rate at 6 months post-Day 1 (PFS 6).

Outcome Time Frame:

6 months post-Day 1

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Glioblastoma
  • Small Cell Glioblastoma
  • Giant Cell Glioblastoma
  • Gliosarcoma
  • Glioblastoma With Oligodendroglial Component
  • Recurrent Glioblastoma
  • Relapsed Glioblastoma
  • Glioblastoma
  • Rindopepimut
  • CDX-110
  • Small cell
  • Giant cell
  • Brain Cancer
  • Brain Tumor
  • Gliosarcoma
  • oligodendroglial
  • radiotherapy
  • chemoradiation
  • Tumor
  • Bevacizumab
  • Relapsed
  • Returned
  • Recurrent
  • EGFR variant III
  • Glioblastoma
  • Gliosarcoma



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