Rindopepimut (CDX-110): Clinical Program
Clinical Program for Malignant Glioblastoma (GB)
Our lead clinical development program, rindopepimut, is an immunotherapy that targets the tumor specific oncogene called EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. While many different epithelial tumors express this antigen, GB has a particularly poor prognosis and is our primary indication at this time.
ACT IV, a Phase 3 confirmatory trial in newly diagnosed, resected GB, and ReACT, a Phase 2 trial in recurrent GB, are currently underway. Click below to learn more about these studies:
| Now Enrolling | |
| Phase 3 Study of Rindopepimut in Patients With Newly Diagnosed Glioblastoma (ACT IV) | |
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| Design: | Phase 3, double-blind, study of rindopepimut compared with KLH control |
| Status: | Currently enrolling at multiple centers in the US; additional centers outside the US planned to be activated in 2012 |
About the Clinical Trial
This 2-arm, randomized, Phase 3 study will investigate the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII positive glioblastoma. All patients will be administered temozolomide. Half the patients will be randomly assigned to receive rindopepimut (given along with GM-CSF as a vaccine adjuvant) and half the patients will be randomly assigned to receive a keyhole limpet hemocyanin (KLH). Patients will be treated in a blinded fashion (neither the patient nor the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.
Patient Eligibility
Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
- Adult patients, ≥ 18 years old
- Newly diagnosed glioblastoma
- At least partial surgical resection followed by conventional chemoradiation
- EGFRvIII positive tumor documented by a central Celldex-designated laboratory
- No evidence of progressive disease from the post-operative period to the post-chemoradiation period
- Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy
- Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at least 3 days prior to randomization
- WHO-ECOG Performance Status ≤ 2
Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
- Stereotactic biopsy only (without further surgical resection)
- Presence of diffuse leptomeningeal disease or gliomatosis cerebri
- History, presence, or suspicion of metastatic disease
- Patients who have received any additional treatment for glioblastoma, aside from surgical resection and chemoradiation with temozolomide
- Active systemic infection requiring treatment
- History of any malignancy (other than glioblastoma) during the last three years except non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer or cured, early-stage prostate cancer in a patient with PSA level less than the upper limit of normal
- Planned major surgery
- Evidence of current drug or alcohol abuse
- 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
Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.
For publications and poster presentations discussing results of prior rindopepimut trials, click here.
| Now Enrolling | |
| Phase 2 Study of Rindopepimut in Patients with Recurrent Glioblastoma (ReACT) | |
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| Design: | Phase 2, double-blind, study of rindopepimut in combination with Avastin® compared to Avastin® with KLH control |
| Status: | Currently enrolling at multiple centers in the US |
About the Clinical Trial
The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of 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.
Patient Eligibility
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- Adult patients, ≥ 18 years old
- Histologic diagnosis of glioblastoma (WHO Grade IV)
- Previous treatment for glioblastoma must include surgery, conventional radiation therapy and temozolomide (TMZ)
- First or second relapse of primary glioblastoma
- Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at least 12 weeks after radiation therapy
- KPS of ≥ 70%
- Life expectancy > 12 weeks
- Documented EGFRvIII positive tumor status by a Sponsor designated laboratory
- If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4mg of dexamethasone or equivalent per day during the week prior to Day 1
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Subjects unable to undergo an MRI with contrast
- History, presence, or suspicion of metastatic disease
- Prior receipt of vaccination against EGFRvIII
- 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
- 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
- Clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Evidence of recent hemorrhage on screening MRI of the brain
- Evidence of current drug or alcohol abuse
Please click here for more information about this trial, including a list of clinical trial sites and contact information for prospective patients.
