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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033616
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date December 19, 2019
Actual Study Start Date  ICMJE November 18, 2017
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
Primary Efficacy Endpoint: Overall Survival [ Time Frame: 5 years ]
Overall Survival: time to death from date of randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
  • Secondary Efficacy Endpoints: Success rate for establishing a tumor cell line [ Time Frame: 5 years ]
    Secondary Efficacy Endpoints: The success rate for establishing patient tumor cell lines
  • Secondary Efficacy Endpoint: Progression Free Survival (PFS) [ Time Frame: 5 years ]
    Progression Free Survival: time to disease progression or death from date of randomization
  • Secondary Efficacy Endpoint: OS and PFS for platinum-sensitive patients [ Time Frame: 5 years ]
    Secondary Efficacy Endpoint: OS and PFS for the subset of patients who are platinum-sensitive and have no evidence of disease (NED) after adjuvant therapy
  • Secondary Efficacy Endpoint: OS and PFS for platinum-resistant patients [ Time Frame: 5 years ]
    Secondary Efficacy Endpoint: OS and PFS for the subset of patients who are platinum-resistant after/during primary adjuvant chemotherapy
  • Secondary Efficacy Endpoints: OS and PFS from date of debulking surgery and diagnosis [ Time Frame: 5 years ]
    Secondary Efficacy Endpoints: OS and PFS from date of debulking surgery and date of diagnosis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 9, 2014)
  • Safety Endpoints: Adverse events attributed to ASI therapy [ Time Frame: Within 30 days from administration ]
    Safety Endpoints: Adverse events attributed to the vaccine therapy (including GM-CSF) and not attributed to chemotherapy to assess safety and tolerability
  • Safety Endpoint: Abnormal findings attributed to the ASI therapy [ Time Frame: Within 30 days from administration ]
    Safety Endpoint: Abnormal findings by history & physical examination, vital signs, clinical laboratory tests (safety), and other tests as clinically indicated that might be attributed to the ASI therapy
 
Descriptive Information
Brief Title  ICMJE Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage III Ovarian Carcinoma
  • Stage IV Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: AVOVA-1
  • Placebo Comparator: MC
    Autologous monocytes will serve as the control arm. MC is admixed with GM-CSF as an adjuvant, prior to injection.
    Intervention: Biological: MC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2014)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Candace Hsieh, PhD 949-872-2555 ext 110 candace@aivitabiomedical.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02033616
Other Study ID Numbers  ICMJE CL-OVA-P01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aivita Biomedical, Inc.
Study Sponsor  ICMJE Aivita Biomedical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.
PRS Account Aivita Biomedical, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP