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GlioblastomaPhase 1NCT01403285

Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma

A Phase 1 study testing Cyclophosphamide, IMA950 plus GM-CSF and IMA950 in people with Glioblastoma, run by Immatics Biotechnologies GmbH at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Cyclophosphamide, IMA950 plus GM-CSF and IMA950
How many people
6 participants
Where
1 siteUnited States
Study dates
Aug 2011to Apr 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)

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.

Read more

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
Glioblastoma
Being tested
Cyclophosphamide, IMA950 plus GM-CSF, IMA950, Imiquimod
Keywords
Glioblastoma, stable disease
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Also called - Cytoxan (US name), - Endoxan (EU name)

    One single low-dose i.v. infusion of cyclophosphamide (300mg/m2) prior to the first vaccination as pre-treatment

  • IMA950 plus GM-CSFBiological

    Also called - Granulocyte macrophage-colony stimulating factor, - Sargramostim, - Leukine

    Six vaccinations with IMA950 plus GM-CSF as adjuvant on 8 pre-defined days from Day 1 to Day 78

  • IMA950Biological

    After Day 78, vaccinations with IMA950 (no GM-CSF) will be given on a monthly basis for up to one year from start of vaccination or until disease progression

  • ImiquimodDrug

    Also called - Aldara

    Imiquimod will be topically applied 10-20 minutes after each vaccination. After the third vaccination onward patients will apply additional imiquimod 24 hours after each vaccination at home on their own

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Number of AEs and percentage of patients with AEs (listed per grade and MedDRA preferred terms) will be reported.

    Measured: Continuously for up to 1 year plus follow-up

  2. Immunogenicity of IMA950

    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.

    Measured: 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination)

Secondary outcomes (5)

  1. Immune status parameters

    Relative frequencies and absolute numbers per µl blood of regulatory T-cells and (if sufficient cells are available) other immune cell populations will be measured from peripheral blood. Focus is on analysis of pre-vaccination frequencies.

    Measured: 6 time points (blood drawings) during the first 3 months on study (pre-vaccination and during vaccination period)

  2. Biomarker assessment and correlation to clinical and immunological response

    Serum levels of proteins and other factors that are indicative of the immune status of the patients will be measured (e.g TGF-beta) and will be correlated with immune response rates and clinical outcome.

    Measured: Analysis time points are before the first vaccination and 15 weeks thereafter

  3. Clinical anti-tumor activity (response rate, 6-month progression-free survival)

    Clinical response rates, survival and progression-free survival (PFS) will be followed. PFS at 6 month will be reported.

    Measured: Will be followed for 1 year (until end of study visit), overall survival will also be followed thereafter

  4. Influence of corticosteroids on immunogenicity of IMA950

    Corticosteroid levels are not limited in this trial. It will descriptively reported whether the known immunosuppressive effects of corticosteroids are reflected in different immune response rates for patients treated or not treated with corticosteroids.

    Measured: 6 time points (blood drawings) during the first 3 months (pre- and post-vaccination)

  5. Health-related quality of life

    FACT-Br(4.0) questionnaire will be used to assess HRQL. HRQL scores (total, Trial Outcome Index, subscales) will be reported at baseline. Changes from baseline will also be evaluated.

    Measured: Monthly for 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionApr 2014
  4. Study completionApr 2014

Why it stopped: Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01403285
Sponsor's protocol ID
IMA950-102
Other IDs
11C0192
Status last verified
May 2014
First submitted
21 Jul 2011
Last updated
19 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide, IMA950 plus GM-CSF and IMA950 in people with Glioblastoma, run by Immatics Biotechnologies GmbH at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to poor accrual. This decision was taken without any safety reasons. Since beginning of the study (June 2011) only six patients were enrolled.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Continuously for up to 1 year plus follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01403285.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.

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