Description:
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).
Title
- Brief Title: Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas
- 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
Clinical Trial IDs
- ORG STUDY ID:
CL-OVA-P01
- NCT ID:
NCT02033616
Conditions
- Stage III Ovarian Carcinoma
- Stage IV Ovarian Carcinoma
- Fallopian Tube Carcinoma
- Primary Peritoneal Carcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| AVOVA-1 | | AVOVA-1 |
| MC | | MC |
Purpose
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).
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
| MC | Placebo Comparator | Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection. | |
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Primary Efficacy Endpoint: Overall Survival |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | Overall Survival: time to death from date of randomization |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Aivita Biomedical, Inc. |
Last Updated
June 1, 2021
