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Epithelial Ovarian CancerPhase 2NCT01068509

Ovarian Cancer Vaccine for Patients in Remission

A Phase 2 study testing Cvac in people with Epithelial Ovarian Cancer, run by Prima BioMed Ltd at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Cvac
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
18 sitesin 2 countries
Study dates
Jul 2010to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

United States13 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Collaborative Research Group

    Boca Raton, Florida, 33487

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Marin Cancer Care, Inc.

    Greenbrae, California, 94904

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Scripps Cancer Center

    La Jolla, California, 92037

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • New York Downtown Hospital

    New York, New York, 10038

  • Stanford University School of Medicine

    Palo Alto, California, 94305

  • University of California, San Francisco

    San Francisco, California, 94115

  • University of Washington Medical Center

    Seattle, Washington, 98109

Other trials in United States

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Peter MacCallum Cancer Cetnre

    East Melbourne, Victoria, 3002

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • Austin Health Cancer Centre

    Heidelberg, Victoria, 3084

  • Gold Coast Hospital

    Southport, Queensland, 4215

Other trials in Australia

About this study

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

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.
Read the 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).

Being tested
Cvac
Keywords
Cvac
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CvacBiological

    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.

Study groups in NCT01068509
Study groupRoleWhat they receive
Non-randomized CvacExperimentalParticipants 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.
Receives: Biological: Cvac
Randomized CvacExperimentalParticipants 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.
Receives: Biological: Cvac
Observational standard of careNo interventionParticipants in this group did not receive any treatment during the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)

Secondary outcomes (3)

  1. Overall Survival

    Overall survival was defined as the time from randomization until death from any cause.

    Measured: Baseline to the end of the study (up to 4 years 10 months)

  2. 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.

    Measured: Baseline to Week 104

  3. 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.

    Measured: Baseline to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2013
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01068509
Sponsor's protocol ID
CAN-003
Status last verified
Jun 2016
First submitted
10 Feb 2010
Last updated
11 May 2017
Data monitoring committee
Yes

Publications

  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

    PubMed 18287387

  • Grossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6. doi: 10.5694/j.1326-5377.2002.tb04616.x.

    PubMed 12088472

  • Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.

  • Markman M, Liu PY, Wilczynski S, Monk B, Copeland LJ, Alvarez RD, Jiang C, Alberts D; Southwest Oncology Group; Gynecologic Oncology Group. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol. 2003 Jul 1;21(13):2460-5. doi: 10.1200/JCO.2003.07.013.

    PubMed 12829663

  • Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. doi: 10.1615/critrevimmunol.v14.i3-4.40.

    PubMed 7538768

  • Desai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).

  • Rustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9. doi: 10.1200/JCO.2000.18.8.1733.

    PubMed 10764434

  • Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. doi: 10.1038/icb.1996.76.

    PubMed 8912009

  • Apostolopoulos V, Karanikas V, Haurum JS, McKenzie IF. Induction of HLA-A2-restricted CTLs to the mucin 1 human breast cancer antigen. J Immunol. 1997 Dec 1;159(11):5211-8.

    PubMed 9548459

  • Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. doi: 10.1054/bjoc.2000.1174.

    PubMed 10789720

  • Liu PY, Alberts DS, Monk BJ, Brady M, Moon J, Markman M. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol. 2007 Aug 20;25(24):3615-20. doi: 10.1200/JCO.2006.09.4540.

    PubMed 17704410

  • Clinical Study Report: A Phase II Trial of Cellular Immunotherapy with M-FP Cancer Vaccine in Subjects with Epithelial Ovarian Cancer, 2007 (with permission from Martin Rogers of Prima Biomed).

  • Immunotherapy for Prostate AdenoCarcinoma Treatment (IMPACT) Phase 3 study summary of sipuleucel-T in castrate-resistant prostate cancer: http://www.bio-medicine.org/medicine-technology-1/

  • Austin Research Institute. SOP #811609. Leukapheresis for ex vivo Culture or Human Dendritic Cells for Immunotherapy. V004, 9 January 2004.

  • Austin Research Institute. SOP #8116 Stages 3-4. Procedures for the ex vivo Generation of MF-P Vaccine Pulsed SC, Phase I Clinical Trial. V006, 10 June 2003.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cvac in people with Epithelial Ovarian Cancer, run by Prima BioMed Ltd at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Baseline to 48 weeks after the last visit or dose of Cvac (up to 104 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068509, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.

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