Clinical trial · Interventional
Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled.
Summary
Brief summary (as posted)
BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming normal cells. IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides (TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific T-cell response against tumor cells leading to decreased likelihood of immune evasion of the tumor by down-regulation of target antigens. PURPOSE: The primary objective of this study is to determine the safety and tolerability of IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor (GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows sufficient immunogenicity in these patients. ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and have stable disease following at least 4 cycles of adjuvant temozolomide.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| IMA950 | Biological | — | UNRESOLVED |
| IMA950 plus GM-CSF | Biological | — | UNRESOLVED |
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Safety and tolerability of IMA950 administered with granulocyte macrophage colony stimulating factor (GM-CSF) and topical imiquimod together following a single low-dose application of cyclophosphamide.
- timeFrame
- Continuously for up to 1 year plus follow-up
- description
- Number of AEs and percentage of patients with AEs (listed per grade and MedDRA preferred terms) will be reported.
- measure
- Immunogenicity of IMA950
- timeFrame
- 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination)
- description
- Vaccine-induced immune responses to peptides contained in IMA950 will be measured by multimer assay using peripheral blood. Percentage of immune responders (patients with at least one vaccine-induced immune response to IMA950 peptides) and percentage of multi-TUMAP responders (patients with vaccine-induced immune responses to ≥2 peptides in IMA950) will be reported.
Secondary outcomes (5)
- measure
- Immune status parameters
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven glioblastoma * Stable disease following ≥ 4 cycles of adjuvant temozolomide * No progression or recurrence of disease PATIENT CHARACTERISTICS: * HLA-A\*02 positive * ≥ 18 years old * Life expectancy \> 8 weeks * Karnofsky performance status ≥ 60 * WBC \>3,500/µL * ALC \>350/mm3 * ANC \>1,500/mm3 * Platelet count \>100,000/mm3 * Hemoglobin \>10gm/dL * AST, ALT and alkaline phosphatase \<2.5 times upper limit of normal (ULN) * Bilirubin \<1.5 times ULN * Creatinine \<1.5 mg/dL and/or creatinine clearance \>60cc/min * Serum potassium, magnesium and calcium within normals levels (supplementation is allowed) * Not pregnant or nursing * Negative pregnancy test * Practice birth control during and for 2 months after treatment with IMA950 (both genders) * Women of childbearing age must agree to use adequate contraceptive methods * No significant active hepatic, renal, infectious or psychiatric disease * No HIV, active hepatitis infection, or any other active severe infectious disease * No history of autoimmune disease or immunosuppression * No clinically significant cardiovascular event within 3 months before study entry or an increased risk for ventricular arrhythmia * No malignancy other than glioblastoma that required treatment during the last 12 months PRIOR and/or CONCURRENT THERAPY: * See Disease Characteristics * Completed radiotherapy and at least 4 cycles of adjuvant temozolomide * Not be receiving steroids OR be on stable dose of steroids for ≥ 5 days prior to registration * No other prior immunotherapy for glioblastoma * No major surgery within 4 weeks prior to treatment start * At least 4 weeks from cytotoxic therapies (incl. temozolomide) * At least 2 weeks from non-cytotoxic therapies (e.g. interferon, tamoxifen) * At least 3 weeks from bevacizumab * No current treatment with imiquimod; prior use of imiquimod is allowed
References
Publications (0)
Data not yet available