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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
Sponsor:
Collaborators:
immatics Biotechnologies GmbH
Oncovir, Inc.
Information provided by (Responsible Party):
Pierre-Yves Dietrich, University Hospital, Geneva

Study Description
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Brief Summary:
RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides have been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent vaccine adjuvant with broad innate and adaptive immune enhancing effects. IMA 950 and Poly-ICLC will be administered to patients alongside standard primary therapy for glioblastoma. This includes the alkylating drug temozolomide (TMZ). Effective vaccine-induced immune responses associated with prolonged survival have been observed in glioblastoma patients during TMZ adjuvant therapy, suggesting a possible synergistic effect. A second component of glioblastoma standard treatment is external beam irradiation of the tumor site post-surgery. As a side effect, potentially beneficial tumor-infiltrating immune cells may also be killed by radiation. However, the combination of radiation with immunotherapy has been suggested to be favorable both in pre-clinical models.

Condition or disease Intervention/treatment Phase
CNS Tumor, Adult Biological: IMA 950 Biological: Poly ICLC Other: Immunomonitoring Phase 1 Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IMA 950 and Poly ICLC Biological: IMA 950
Biological: Poly ICLC
Other Name: Hiltonol

Other: Immunomonitoring
Blood samples, DTH analysis


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival (OS) [ Time Frame: up to 2 years ]
  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Patients must have completed radiation therapy with concomitant temozolomide.
  3. HLA-A2 positive.
  4. Eastern Cooperative Oncology Group performance status of 0 or 1 (Appendix1).
  5. Age > 18 years, life expectancy of least 4 months.
  6. Patient must be on stable or decreasing dose of steroids, with a maximal dose of Dexamethasone of 4mg/day.
  7. Adequate bone marrow, liver and kidney function.
  8. Hepatitis B serology negative (HBcAg-seronegative)
  9. Written (signed and dated) informed consent. Capable of co-operating with standard therapy and IMA950 with Poly-ICLC vaccinations and follow-up.

Exclusion Criteria:

  1. Any other vaccination given within 2 weeks before first IMA950 vaccination.
  2. History of cardiac disease: congestive heart failure > New York heart association class 2, active CAD, cardiac requiring anti-arrhythmic therapy or uncontrolled hypertension.
  3. History of HIV infection or chronic hepatitis B or C or clinical active infections.
  4. Patients with evidence of history bleeding diathesis.
  5. 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Switzerland
Geneva University Hospitals, Centre of Oncology
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Geneva
immatics Biotechnologies GmbH
Oncovir, Inc.
Investigators
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Principal Investigator: Pierre-Yves Dietrich, Professor University Hospital, Geneva
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pierre-Yves Dietrich, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01920191     History of Changes
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
Keywords provided by Pierre-Yves Dietrich, University Hospital, Geneva:
Glioblastoma
Additional relevant MeSH terms:
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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 I-C
Carboxymethylcellulose Sodium
Poly ICLC
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Laxatives
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents