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Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas

Primary Purpose

Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

AVOVA-1

About this trial

This is an interventional treatment trial for Stage III Ovarian Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Disney Family Cancer Center
Scripps Health
UC San Diego, Moores Cancer Center
Hoag Memorial Hospital Presbyterian
UC Irvine, Chao Family Comprehensive Cancer Center
University of Colorado Hospital - Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AVOVA-1

Arm Description

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.

Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection.

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint: Overall Survival

Overall Survival: time to death from date of randomization

Secondary Outcome Measures

Full Information

NCT ID

NCT02033616

First Posted

January 7, 2014

Last Updated

April 21, 2022

Sponsor

Aivita Biomedical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02033616

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 18, 2017 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aivita Biomedical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Ovarian Carcinoma, Stage IV Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AVOVA-1

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection.

Intervention Type

Biological

Intervention Name(s)

AVOVA-1

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Intervention Description

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoint: Overall Survival

Description

Overall Survival: time to death from date of randomization

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert O Dillman, MD

Organizational Affiliation

Aivita Biomedical, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Disney Family Cancer Center

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Scripps Health

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

UC San Diego, Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92658

Country

United States

Facility Name

UC Irvine, Chao Family Comprehensive Cancer Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

University of Colorado Hospital - Cancer Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas

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