Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma
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ClinicalTrials.gov Identifier: NCT01920191 |
Recruitment Status :
Completed
First Posted : August 9, 2013
Last Update Posted : April 20, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CNS Tumor, Adult | Biological: IMA 950 Biological: Poly ICLC Other: Immunomonitoring | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Intradermal IMA950 Peptide-based Vaccine Adjuvanted With Intra Muscular Poly-ICLC in Combination With Temozolomide in Newly Diagnosed HLA-A2 Glioblastoma Patients |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: IMA 950 and Poly ICLC |
Biological: IMA 950 Biological: Poly ICLC Other Name: Hiltonol Other: Immunomonitoring Blood samples, DTH analysis |
- Tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with temozolomide, using CTCAE V 4.0 [ Time Frame: up to 2 years ]
- 6, 9 month progression free survival (PFS) using gadolinium enhanced MRI and clinical assessment according to revised RANO criteria [ Time Frame: up to 2 years ]
- Overall survival (OS) [ Time Frame: up to 2 years ]
- Immunologic endpoints [ Time Frame: up to 2 years ]
Correlation between clinical and immunological response. Blood sampling at baseline (week 4 and 5 after beginning of radiotherapy with concomitant temozolomide) and at week 10,11,12,16,19,23,27 and 31.
Punch biopsy at DTH (Delayed Type Hypersensitivity) site performed 48h after DTH skin test 7 days after Vaccination 7.
- evaluation of peptide immunogenicity by tetramer staining
- analysis of memory, activation and homing marker expression by tetramer positive cells
- analysis of cytokine secretion and proliferation by antigen-specific CD4 and CD8 T cells
- analysis of the presence of T regulatory and myeloid-derived suppressor cells

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological documentation of glioblastoma. For experimental purposes only, 5 additional grade III astrocytoma may be included (these cases will not be included in the endpoints analysis).
- Patients must have completed radiation therapy with concomitant temozolomide.
- HLA-A2 positive.
- Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix1).
- Age > 18 years, life expectancy of least 4 months.
- Patient must be on stable or decreasing dose of steroids, with a maximal dose of Dexamethasone of 4mg/day.
- Adequate bone marrow, liver and kidney function.
- Hepatitis B serology negative (HBcAg-seronegative)
- Written (signed and dated) informed consent. Capable of co-operating with standard therapy and IMA950 with Poly-ICLC vaccinations and follow-up.
Exclusion Criteria:
- Any other vaccination given within 2 weeks before first IMA950 vaccination.
- History of cardiac disease: congestive heart failure > New York heart association class 2, active CAD, cardiac requiring anti-arrhythmic therapy or uncontrolled hypertension.
- History of HIV infection or chronic hepatitis B or C or clinical active infections.
- Patients with evidence of history bleeding diathesis.
- Pregnant or potentially pregnant patients. Women of childbearing age must be tested for pregnancy (serum or urine HCG) before treatment and must not contemplate pregnancy during the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920191
Switzerland | |
Geneva University Hospitals, Centre of Oncology | |
Geneva, Switzerland, CH-1211 |
Principal Investigator: | Pierre-Yves Dietrich, Professor | University Hospital, Geneva |
Responsible Party: | Pierre-Yves Dietrich, Professor, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT01920191 |
Other Study ID Numbers: |
IMA950 Poly ICLC |
First Posted: | August 9, 2013 Key Record Dates |
Last Update Posted: | April 20, 2016 |
Last Verified: | April 2016 |
Glioblastoma |
Glioblastoma Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs |