Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma

NCT01920191 | Completed Phase 1 DMC

• 1 other identifier: IMA950 Poly ICLC
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Tumor, Adult

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with temozolomide, using CTCAE V 4.0

  up to 2 years

Secondary Outcomes (3)

• 6, 9 month progression free survival (PFS) using gadolinium enhanced MRI and clinical assessment according to revised RANO criteria

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Immunologic endpoints

  up to 2 years

Study Arms (1)

IMA 950 and Poly ICLC

EXPERIMENTAL

Biological: IMA 950; Biological: Poly ICLC; Other: Immunomonitoring

Interventions

IMA 950 BIOLOGICAL

IMA 950 and Poly ICLC

Poly ICLC BIOLOGICAL

Also known as: Hiltonol

IMA 950 and Poly ICLC

Immunomonitoring OTHER

Blood samples, DTH analysis

IMA 950 and Poly ICLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Immatics Biotechnologies GmbH: collaborator
• Oncovir, Inc.: collaborator

Study Sites (1)

Geneva University Hospitals, Centre of Oncology

Geneva, CH-1211, Switzerland

Location

Related Publications (1)

• Migliorini D, Dutoit V, Allard M, Grandjean Hallez N, Marinari E, Widmer V, Philippin G, Corlazzoli F, Gustave R, Kreutzfeldt M, Blazek N, Wasem J, Hottinger A, Koka A, Momjian S, Lobrinus A, Merkler D, Vargas MI, Walker PR, Patrikidou A, Dietrich PY. Phase I/II trial testing safety and immunogenicity of the multipeptide IMA950/poly-ICLC vaccine in newly diagnosed adult malignant astrocytoma patients. Neuro Oncol. 2019 Jul 11;21(7):923-933. doi: 10.1093/neuonc/noz040.

  PMID: 30753611 DERIVED

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Pierre-Yves Dietrich, Professor

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CH (1)