Back to resultsOvarian Cancer Vaccine for Patients in Remission
Primary Purpose
Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cvac
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Cvac
Eligibility Criteria
Inclusion Criteria:
- Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
- Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125.
- Able and willing to undergo mononuclear cell collection.
- Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
- No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
- No prior treatment with an investigational product within 30 days of enrollment.
- Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
- Serum creatinine ≤ 2 mg/dL.
- Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal.
- White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
- Life expectancy of at least 12 months.
- Eastern Cooperative Oncology Group Performance Status of 0-1.
- All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1.
- Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
- Able to provide written informed consent.
Exclusion Criteria:
- Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.
- Ovarian germ cell, sarcoma, or mixed Mullerian tumors.
- Prior cancer vaccine or cellular therapy.
- Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common Terminology Criteria for Adverse Events criteria.
- Inability to provide informed consent or to comply with study-related procedures.
- Concurrent systemic treatment with steroids or other immunosuppressive agents.
- Diagnosed immunodeficiency and/or autoimmune disorders.
- Myocardial infarction in the past 6 months and/or clinically significant heart disease.
- Infection with human immunodeficient virus (HIV), hepatitis B or C virus.
- Pregnant or breastfeeding.
- Evidence or history of central nervous system metastases.
- Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.
- Hematopoietic growth factors administered within 14 days of enrollment.
Sites / Locations
- Marin Cancer Care, Inc.
- Scripps Cancer Center
- Stanford University School of Medicine
- University of California, San Francisco
- Collaborative Research Group
- Northside Hospital
- Indiana University Simon Cancer Center
- Morristown Medical Center
- New York Downtown Hospital
- Duke University Medical Center
- Cleveland Clinic Foundation
- Medical University of South Carolina
- University of Washington Medical Center
- Greenslopes Private Hospital
- Gold Coast Hospital
- Royal Adelaide Hospital
- Peter MacCallum Cancer Cetnre
- Austin Health Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Non-randomized Cvac
Randomized Cvac
Observational standard of care
Arm Description
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
Participants in this group did not receive any treatment during the study.
Outcomes
Primary Outcome Measures
Progression-free Survival
Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.
Secondary Outcome Measures
Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104
Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104
Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01068509
Brief Title
Ovarian Cancer Vaccine for Patients in Remission
Official Title
A Randomized, Open-label Phase IIb Trial of Maintenance Therapy With a MUC1 Dendritic Cell Vaccine (Cvac™) for Epithelial Ovarian Cancer Patients in First or Second Remission
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prima BioMed Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of an investigational therapeutic agent (Cvac) in ovarian cancer patients in first or second remission and to determine its ability to prevent cancer from returning.
Study objectives
Primary objectives:
To confirm the safety of administering Cvac in this population.
To determine the effects of Cvac on progression-free survival (PFS).
Secondary objectives:
To determine overall survival (OS) for ovarian cancer patients who receive Cvac after achieving remission in the first or second-line setting.
Evaluation of host immunologic response to Cvac administration.
Detailed Description
An initial cohort of 7 patients were treated with Cvac in an open-label phase to confirm the safety and consistency of manufacturing between Cvac drug product manufactured in the United States (US) and Australia. After the manufacturing characteristics of Cvac were confirmed to be consistent and each patient in the initial cohort had completed 1 injection cycle of Cvac with no serious or treatment-related Grade 3 or 4 adverse events (AEs), 56 patients were enrolled and randomized (1:1) to either Cvac or observational standard of care (OSC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
Cvac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-randomized Cvac
Arm Type
Experimental
Arm Description
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
Arm Title
Randomized Cvac
Arm Type
Experimental
Arm Description
Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
Arm Title
Observational standard of care
Arm Type
No Intervention
Arm Description
Participants in this group did not receive any treatment during the study.
Intervention Type
Biological
Intervention Name(s)
Cvac
Intervention Description
Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression-free survival was defined as the time from randomization to the date of documented disease progression or death from any cause, whichever occurred earlier. Disease progression occurred when a patient met either the Gynecologic Cancer Intergroup (GCIG) cancer-antigen (CA)-125 definition or the Response Evaluation Criteria in Solid Tumors (RECIST) radiological definition of progressive disease. The GCIG CA-125 definition of disease progression was defined as a CA-125 level ≥ 2 × the upper limit of normal documented on 2 occasions at least 1 week apart. The radiological RECIST criteria of disease progression was defined as the appearance of new lesions or an overall increase ≥ 20% or at least 5 mm in existing tumors.
Time Frame
Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization until death from any cause.
Time Frame
Baseline to the end of the study (up to 4 years 10 months)
Title
Change From Baseline in Mucin 1 Antibody Levels at Weeks 20, 56, and 104
Description
Mucin 1 antibodies were assessed in serum samples using a quantitative enzyme-linked immunosorbent assay (ELISA). Detection was achieved with electrochemiluminescence.
Time Frame
Baseline to Week 104
Title
Change From Baseline in ICS of IL2, IL4, IL17, TNF, and IFNg in CD4+ and CD8+ Cells at Weeks 20, 56, and 104
Description
Intracellular cytokine staining (ICS) for IL2, IL4, IL17, tumor necrosis factor (TNF), and interferon gamma (IFNg) was done in both CD4+ and CD8+ cells from serum samples collected at Weeks, 20, 56, and 104. Intracellular cytokine staining data were acquired with 8-color flow cytometry on a BD LSR II flow cytometer and a high-throughput screening microplate reader.
Time Frame
Baseline to Week 104
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female subjects ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer who have previously undergone surgical cytoreduction and received first or second line conventional chemotherapy and are currently in complete remission (based on clinical and radiologic studies).
Cancer antigen (CA)-125 ≤ upper limit of normal with a prior history of an elevated CA-125.
Able and willing to undergo mononuclear cell collection.
Not more than 12 weeks between enrollment and the last dose of chemotherapy that resulted in complete remission.
No prior surgery to the peritoneum or pleural space within 28 days of enrollment, excluding removal of catheters used for chemotherapy administration.
No prior treatment with an investigational product within 30 days of enrollment.
Baseline electrocardiogram within normal limits or any abnormalities deemed not indicative of cardiac disease for which intervention is required.
Serum creatinine ≤ 2 mg/dL.
Serum aspartate aminotransferase or serum alanine aminotransferase ≤ 2.5x the upper limit of normal or serum total bilirubin ≤ 1.5x the upper limit of normal.
White blood cell count ≥ 3.0 K/µL; absolute neutrophil count ≥ 1.5K/µL; hemoglobin ≥ 9.0 g/dL, and platelets ≥ 100,000/mm^3. (These complete blood count results are required for enrollment. It should be noted that complete blood count results, including monocyte count ≥ 0.2 × 10^9/L, will be needed prior to leukapheresis to determine if sufficient dendritic cells can be obtained for Cvac™ manufacture.)
Life expectancy of at least 12 months.
Eastern Cooperative Oncology Group Performance Status of 0-1.
All toxicities from prior therapies, excluding alopecia, must have resolved to Common Terminology Criteria for Adverse Events Grade ≤ 1.
Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion.
Able to provide written informed consent.
Exclusion Criteria:
Coexisting or other malignancies unless in complete remission for not less than 3 years. Does not include in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin for which no restrictions apply, assuming they have been adequately treated.
Ovarian germ cell, sarcoma, or mixed Mullerian tumors.
Prior cancer vaccine or cellular therapy.
Active uncontrolled infections or any organ system toxicity ≥ Grade 2 by Common Terminology Criteria for Adverse Events criteria.
Inability to provide informed consent or to comply with study-related procedures.
Concurrent systemic treatment with steroids or other immunosuppressive agents.
Diagnosed immunodeficiency and/or autoimmune disorders.
Myocardial infarction in the past 6 months and/or clinically significant heart disease.
Infection with human immunodeficient virus (HIV), hepatitis B or C virus.
Pregnant or breastfeeding.
Evidence or history of central nervous system metastases.
Full dose anticoagulation therapy administered within 7 days of leukapheresis procedure.
Hematopoietic growth factors administered within 14 days of enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Gray, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Moradi, MD
Organizational Affiliation
New York Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Berek, MD, MMS
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nana Tchabo, MD
Organizational Affiliation
Morristown Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Young, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Mason, MD
Organizational Affiliation
Scripps Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angeles Secord, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Eisenberg, MD
Organizational Affiliation
Marin Cancer Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giuseppe Del Priore, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Rose, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Recio, MD
Organizational Affiliation
Collaborative Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benedict Benigno, MD
Organizational Affiliation
Northside Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Chan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Mitchell, MB ChB
Organizational Affiliation
Austin Health Cancer Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Mileshkin, MBBS
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Davy, MBBS, CGO
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Goh, MBBS, FRACP
Organizational Affiliation
Greenslopes Private Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Matos, FRACP
Organizational Affiliation
Gold Coast Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marin Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Collaborative Research Group
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
New York Downtown Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Greenslopes Private Hospital
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Cetnre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin Health Cancer Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
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Ovarian Cancer Vaccine for Patients in Remission
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