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

• ClinicalTrials.gov Identifier: NCT02033616
• Recruitment Status: Active, not recruiting
• First Posted: January 13, 2014
• Last Update Posted: April 25, 2022
• Sponsor: Aivita Biomedical, Inc.
• Information provided by (Responsible Party): Aivita Biomedical, Inc.

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).

Condition or disease	Intervention/treatment	Phase
Stage III Ovarian Carcinoma; Stage IV Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Carcinoma	Biological: AVOVA-1; Biological: MC	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 18, 2017
• Actual Primary Completion Date: March 15, 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: AVOVA-1; 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.	Biological: AVOVA-1; 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.
Placebo Comparator: MC; Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection.	Biological: MC; 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.

Outcome Measures

Primary Outcome Measures :

1. Primary Efficacy Endpoint: Overall Survival [ Time Frame: 5 years ]
   Overall Survival: time to death from date of randomization

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Disney Family Cancer Center

Burbank, California, United States, 91505

Scripps Health

La Jolla, California, United States, 92037

UC San Diego, Moores Cancer Center

La Jolla, California, United States, 92093

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92658

UC Irvine, Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

United States, Colorado

University of Colorado Hospital - Cancer Center

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

Aivita Biomedical, Inc.

Investigators

• Study Chair: Robert O Dillman, MD; Aivita Biomedical, Inc.

More Information

• Responsible Party: Aivita Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT02033616
• Other Study ID Numbers: CL-OVA-P01
• First Posted: January 13, 2014
• Last Update Posted: April 25, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders