Stage III Ovarian CarcinomaPhase 2NCT02033616
Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas
A Phase 2 study testing AVOVA-1 and MC in people with Stage III Ovarian Carcinoma and Stage IV Ovarian Carcinoma, run by Aivita Biomedical, Inc. at 6 sites in United States.
Trial summary
This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma
- What is being tested?
- AVOVA-1 and MC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Nov 2017to Mar 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status of 0-1 (Karnofsky score of 70-100%)
- Successful establishment of an autologous epithelial ovarian, fallopian tube, or primary peritoneal cancer cell line by AIVITA Biomedical, Inc.
- Patients must previously have been staged as having stage III [intraperitoneal (IP)] or Stage IV (distant metastatic) ovarian, fallopian tube, or primary peritoneal cancer, have undergone surgical debulking, and have initiated or completed standard adjuvant chemotherapy, which may include intravenous (IV) and/or IP chemotherapy using standard regimens. Patients will be characterized as being NED or non-NED per physical exam, CT and/or PET scans, and CA-125.
- Have undergone leukapheresis from which sufficient provided PBMC were obtained to produce an investigational treatment.
- Patients with one or a few brain metastases that have been treated with stereotactic radiotherapy consisting of a single dose, such as Gamma Knife or Cyberknife, are allowed to be included in the study, but need wait one week after such treatment.
- Written informed consent for treatment with investigational treatment
Who cannot join
- Known to have active hepatitis B or C or HIV
- ECOG performance status greater than 1 (Karnofsky score less than 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 ovarian (such as continuation of hormonal therapy for prostate or breast cancer diagnosed more than five years earlier).
- Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis.
- Active central nervous system metastases at the time of treatment.
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- Known autoimmune disease, immunodeficiency, or disease process that involves the use of immunosuppressive therapy.
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Hospital - Cancer Center
Aurora, Colorado, 80045
Disney Family Cancer Center
Burbank, California, 91505
Scripps Health
La Jolla, California, 92037
UC San Diego, Moores Cancer Center
La Jolla, California, 92093
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
UC Irvine, Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: Phase II, Double-Blind, Randomized Trial Of AVOVA-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens) Vs. Autologous Peripheral Blood Mononuclear Cells (MC) In Patients With Stage III Or IV Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma After Primary Therapy
This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient PMBC were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).
The primary endpoint of this trial is death from any cause with the metric of OS from the date of randomization. PFS will be a secondary endpoint and will be calculated as the time from the date of randomization for treatment until subjective tumor progression or death. Progression will be subjectively defined by the treating physician, and is expected to be based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of debulking surgery.
Patients will be stratified into (1) no evidence of disease (NED) (no measurable or non-measurable disease per RECIST and normal CA-125 levels) or (2) non-NED (measurable or non-measurable disease per RECIST or elevated CA-125 levels).
- Conditions
- Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Being tested
- AVOVA-1, MC
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVOVA-1Biological
Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.
MCBiological
Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.
| Study group | Role | What they receive |
|---|---|---|
| AVOVA-1 | Experimental | Autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells. AVOVA-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection. Receives: Biological: AVOVA-1 |
| MC | Placebo comparator | Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection. Receives: Biological: MC |
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 randomization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start18 Nov 2017
- Primary completion15 Mar 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Ovarian CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 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
- NCT02033616
- Sponsor's protocol ID
- CL-OVA-P01
- Status last verified
- Apr 2022
- First submitted
- 7 Jan 2014
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double-Blind, Randomized Trial Of AVOVA-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens) Vs. Autologous Peripheral Blood Mononuclear Cells (MC) In Patients With Stage III Or IV Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma After Primary Therapy
- ClinicalTrials.gov ID
- NCT02033616
- Acronym / sponsor ID
- CL-OVA-P01
- Conditions
- Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Aivita Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- 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 double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient PMBC were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%).
The primary endpoint of this trial is death from any cause with the metric of OS from the date of randomization. PFS will be a secondary endpoint and will be calculated as the time from the date of randomization for treatment until subjective tumor progression or death. Progression will be subjectively defined by the treating physician, and is expected to be based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of debulking surgery.
Patients will be stratified into (1) no evidence of disease (NED) (no measurable or non-measurable disease per RECIST and normal CA-125 levels) or (2) non-NED (measurable or non-measurable disease per RECIST or elevated CA-125 levels).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVOVA-1 | Experimental | Biological: AVOVA-1Autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells. AVOVA-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection. |
| MC | Placebo comparator | Biological: MCAutologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG performance status of 0-1 (Karnofsky score of 70-100%)
- Successful establishment of an autologous epithelial ovarian, fallopian tube, or primary peritoneal cancer cell line by AIVITA Biomedical, Inc.
- Patients must previously have been staged as having stage III [intraperitoneal (IP)] or Stage IV (distant metastatic) ovarian, fallopian tube, or primary peritoneal cancer, have undergone surgical debulking, and have initiated or completed standard adjuvant chemotherapy, which may include intravenous (IV) and/or IP chemotherapy using standard regimens. Patients will be characterized as being NED or non-NED per physical exam, CT and/or PET scans, and CA-125.
- Have undergone leukapheresis from which sufficient provided PBMC were obtained to produce an investigational treatment.
- Patients with one or a few brain metastases that have been treated with stereotactic radiotherapy consisting of a single dose, such as Gamma Knife or Cyberknife, are allowed to be included in the study, but need wait one week after such treatment.
Key exclusion criteria (9 listed)
- Known to have active hepatitis B or C or HIV
- ECOG performance status greater than 1 (Karnofsky score less than 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 ovarian (such as continuation of hormonal therapy for prostate or breast cancer diagnosed more than five years earlier).
- 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 |
|---|---|---|
| AVOVA-1Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells. | Biological | AVOVA-1 |
| MCComparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells. | Biological | MC |
Primary outcome
Primary Efficacy Endpoint: Overall Survival
Time frame: 5 years
Overall Survival: time to death from date of randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
6 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 AVOVA-1 and MC in people with Stage III Ovarian Carcinoma and Stage IV Ovarian Carcinoma, run by Aivita Biomedical, Inc. at 6 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.