Newly Diagnosed GlioblastomaPhase 2NCT03400917
Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma
A Phase 2 study testing AV-GBM-1 in people with Newly Diagnosed Glioblastoma, run by Aivita Biomedical, Inc. at 8 sites in United States.
Trial summary
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Newly Diagnosed Glioblastoma
- What is being tested?
- AV-GBM-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Jun 2018to Feb 2023
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Karnofsky Performance Score of 70-100%
- Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)
- Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.
- Collection of a satisfactory leukapheresis product
- About to begin concurrent CT/RT
- Given written informed consent to participate in the study
Who cannot join
- Known to have active hepatitis B or C or HIV
- Karnofsky Performance Score of < 70%
- Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
- Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than GBM
- Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
- Known autoimmune disease, immunodeficiency, or disease process that involves the chronic use of immunosuppressive therapy.
Show all 9Show fewer
- Received another investigational drug within 28 days of the first dose or are planning to receive another investigational drug while receiving this investigational treatment.
- Known hypersensitivity to GM-CSF
- Pregnancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Scripps Health
La Jolla, California, 92037
UC San Diego Moores Cancer Center
La Jolla, California, 92037
Norton Cancer Institute
Louisville, Kentucky, 40202
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
UC Irvine Medical Center
Orange, California, 92868
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).
Read the detailed description
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).
The primary endpoint of this trial is overall survival (OS), death from any cause measured from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection. Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.
Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an autologous tumor cell culture and leukapheresis product are available, who have a KPS of > 70, and who are about to begin concurrent CT/RT.
- Conditions
- Newly Diagnosed Glioblastoma
- Being tested
- AV-GBM-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-GBM-1Biological
Investigational treatment with AV-GBM-1
| Study group | Role | What they receive |
|---|---|---|
| AV-GBM-1 | Experimental | Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection. Receives: Biological: AV-GBM-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Overall Survival
Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start20 Jun 2018
- Primary completion1 Dec 2021
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aivita Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert O Dillman, MD, Study chair, Aivita Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400917
- Sponsor's protocol ID
- CL-GBM-P01
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bota DA, Taylor TH, Piccioni DE, Duma CM, LaRocca RV, Kesari S, Carrillo JA, Abedi M, Aiken RD, Hsu FPK, Kong XT, Hsieh C, Bota PG, Nistor GI, Keirstead HS, Dillman RO. Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. J Exp Clin Cancer Res. 2022 Dec 14;41(1):344. doi: 10.1186/s13046-022-02552-6.
PubMed 36517865
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03400917
- Acronym / sponsor ID
- CL-GBM-P01
- Conditions
- Newly Diagnosed Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Aivita Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- Feb 2023 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients with newly diagnosed glioblastoma (GBM) will be enrolled with the intent to receive an autologous dendritic cell vaccine consisting of autologous dendritic cells loaded with autologous tumor-associated antigens (AV-GBM-1).
Detailed description
This is a single-arm, open-label phase II clinical trial in which approximately 55 patients will be enrolled with the intent to receive AV-GBM-1. Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a KPS of > 70, and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).
The primary endpoint of this trial is overall survival (OS), death from any cause measured from the date of study enrollment for treatment with AV-GBM-1. Secondary endpoints will include (1) PFS measured from date of enrollment, (2) OS/PFS measured from date of diagnosis and (3) OS/PFS from date of enrollment based on KPS, age, and extent of surgical resection. Tertiary endpoints will include (1) OS/PFS from date of first injection and (2) OS/PFS from date of first injection in patients who completed concurrent CT/RT and had not progressed.
Patient Population: Patients 18 years or older with newly diagnosed glioblastoma [World Health Organization (WHO) Grade IV glioma, Grade IV anaplastic astrocytoma, glioblastoma or gliosarcoma, glioblastoma multiforme (GBM)] who have recovered from surgery, for whom an autologous tumor cell culture and leukapheresis product are available, who have a KPS of > 70, and who are about to begin concurrent CT/RT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AV-GBM-1 | Experimental | Biological: AV-GBM-1Autologous dendritic cells loaded with tumor associated antigens from a short-term cell culture of autologous tumor cells. AV-GBM-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Karnofsky Performance Score of 70-100%
- Histology confirmed to be GBM (Grade IV WHO, glioblastoma, gliosarcoma)
- Successful establishment of an autologous cancer cell line by AIVITA Biomedical, Inc.
- Collection of a satisfactory leukapheresis product
- About to begin concurrent CT/RT
Key exclusion criteria (9 listed)
- Known to have active hepatitis B or C or HIV
- Karnofsky Performance Score of < 70%
- Known underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease
- Diagnosis of any other invasive cancer or other disease process which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than GBM
- Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-GBM-1Investigational treatment with AV-GBM-1 | Biological | AV-GBM-1 |
Primary outcome
Primary Efficacy Endpoint: Overall Survival
Time frame: 3 years
Overall Survival: time to death from date of enrollment for intent-to-treat with AV-GBM-1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 36517865Bota DA, Taylor TH, Piccioni DE, Duma CM, LaRocca RV, Kesari S, Carrillo JA, Abedi M, Aiken RD, Hsu FPK, Kong XT, Hsieh C, Bota PG, Nistor GI, Keirstead HS, Dillman RO. Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment. J Exp Clin Cancer Res. 2022 Dec 14;41(1):344. doi: 10.1186/s13046-022-02552-6.
Related trials for Newly Diagnosed Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Active, not recruitingPhase 1/2
A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Active, not recruitingPhase 2
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma
Anaplastic Astrocytoma, Anaplastic Astrocytoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O Dillman, MD study chair
Aivita Biomedical, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV-GBM-1 in people with Newly Diagnosed Glioblastoma, run by Aivita Biomedical, Inc. at 8 sites 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?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Primary Efficacy Endpoint: Overall Survival (time frame: 3 years). 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 NCT03400917, which also lists 1 linked publication.
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 16 Dec 2021.