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Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy or Second-Line Treatment (CANVAS)

This study has been terminated.
(Trial terminated per Sponsor direction not due to any safety signal but due to longer than expected clinical & regulatory approvals & enrolment of patients.)
Information provided by (Responsible Party):
Prima BioMed Ltd Identifier:
First received: January 17, 2012
Last updated: April 1, 2015
Last verified: April 2015

The purpose of this study is to determine if an investigational cell therapy called Cvac can help EOC from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line or second-line chemotherapy.

Following remission, patients will undergo leukapheresis for manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.

Condition Intervention Phase
Epithelial Ovarian Cancer
Biological: Placebo
Biological: Cvac
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CANVAS: A Randomized Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein [Mucin 1-Glutathione S Transferase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients With Epithelial Ovarian Cancer (EOC) in Second Remission

Resource links provided by NLM:

Further study details as provided by Prima BioMed Ltd:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Participants will be followed from randomization until the date of death from any cause or end of study, whichever comes first, assesessed every 24 weeks. ] [ Designated as safety issue: No ]
    Assess Cvac as compared to placebo or Standard of Care (SOC) for overall survival

Secondary Outcome Measures:
  • Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy or second-line treatment [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, or end of study, whichever comes first. ] [ Designated as safety issue: No ]
    PFS is defined as the time from randomization to the date of radiological scan used to determine PD, evaluated every 12 weeks after baseline.

  • Assessment of safety and tolerability of Cvac as compared to placebo or SOC [ Time Frame: 10 - 12 months ] [ Designated as safety issue: Yes ]
    Evaluated by AEs, laboratory test results, ECGs, physical examinations, and vital signs

  • Assessment of health-related quality of life questionnaires(QoL) [ Time Frame: From baseline and throughout PFS. ] [ Designated as safety issue: No ]
    Quality-of-life data will be derived from the quality of life questionnaires according to the corresponding scoring manuals and will be summarized for each treatment group. Patients' health states will be derived from the EQ-5D-3L questionnaire. Data will be summarized by treatment group and analyzed using descriptive statistics.

Enrollment: 132
Study Start Date: January 2012
Study Completion Date: April 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (Part A - First Remission)
Part A is closed to recruitment
Biological: Placebo
Study agent dosing will be administered as an intradermal injection every 4 weeks for the first 3 doses, then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
Active Comparator: Cvac
Cvac as compared with placebo or SOC for the maintenance treatment of patients with EOC in CR following first line remission (Closed to recruitment) or Second-line remission (Open to recruitment).
Biological: Cvac
Study agent dosing will be administered as an intradermal injection every 4 weeks for the first 3 doses, then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
No Intervention: Observational Standard of Care
Part B - Second-line Remission

Detailed Description:

This study proposes a nontoxic immunotherapeutic approach to extend the overall survival in patients in complete remission.

Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and first-line platinum-based chemotherapy. However, most patients, despite high response rates to first-line treatment, will relapse and undergo subsequent lines of chemotherapy. Generally, the progression-free interval between treatments becomes shorter with each relapse, and the patient eventually dies of the disease.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Part A - First Remission: Closed to Recruitment

Part B - Second Remission: Open to Recruitment

Inclusion Criteria (Part B):

  1. Females ≥ 18 years of age at screening with a confirmed diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer
  2. Underwent standard cytoreductive surgery and first-line chemotherapy containing platinum before first relapse and were in complete remission for at least 6 months prior to relapse
  3. Relapsed once and then underwent standard platinum-based second-line chemotherapy (at least 3 cycles is required) with or without a second bulk-reducing surgery
  4. Second remission defined as:

    1. No definitive evidence of disease (NED) on CT or MRI of the abdomen and pelvis;
    2. CA-125 ≤ upper limit of normal (ULN) or 90% reduction in CA-125 since start of second-line chemotherapy;
    3. Negative physical exam (i.e., no clinical signs)
  5. Life expectancy ≥ 3 months in the opinion of the investigator
  6. Signed an informed consent form (ICF)
  7. Willing and able to complete study procedures within the expected study timelines
  8. Mucin 1-positive tumor as determined by central immunohistopathology
  9. Histologically documented EOC, fallopian tube, or peritoneal cancer (patients with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, i.e., patients with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
  10. Adequate end-organ and hematological function as defined by:

    1. Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 K/µL, absolute neutrophil count (ANC) ≥ 1.5 × 109

      • L, hemoglobin ≥ 9 g/dL, and platelets

        ≥ 100 × 109

      • L
    2. Adequate renal function: serum creatinine ≤ 1.5 × ULN
    3. Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN
  11. Generally well-controlled blood pressure with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg prior to randomization (antihypertensive medications are permitted). Low-dose chronic hormonal or steroidal treatments are also permitted.
  12. Not pregnant, and if of childbearing potential, agrees to use a highly effective method of birth control (implanted, injectable, or oral combination hormonal method alone or in possible combinations, intrauterine device, vasectomized partner, or abstinence) prior to study entry, for the duration of the study, and for 3 months after the last dose of study agent. Male partners of a study patient must use a condom in addition to the acceptable method of contraception for the female partner as specified above
  13. ECOG status of 0 or 1 (applicable at the baseline visit only).

Exclusion Criteria (Part B):

Patients are to be excluded from the study at the time of screening and the baseline visit (defined as the visit within 2 weeks of the first dose) for any of the following reasons:

  1. More than 2 previous lines of chemotherapy for EOC, fallopian tube, or peritoneal cancer
  2. Primary platinum-refractory or platinum-resistant disease (i.e., patients who progress prior to cessation of induction therapy [platinum refractory] or recur within 6 months after cessation [platinum resistant])
  3. Treatment with any investigational product (for any condition) within 4 weeks of screening. Enrolled in or has not completed at least 28 days (prior to screening) since ending another investigational device or drug treatment, or currently receiving other investigational treatments
  4. Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
  5. Evidence of severe or uncontrolled cardiac disease, including myocardial infarction or unstable angina within 6 months of screening, congestive heart failure, or ventricular arrhythmias requiring medication
  6. Diagnosed immunodeficiency or autoimmune disorder
  7. Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
  8. Pregnant or lactating
  9. Evidence or history of central nervous system metastasis
  10. Known hypersensitivity to any of the components of the study agent
  11. Any unresolved persistent toxicities from prior systemic therapy that are either Grade 3 or Grade 4 (except alopecia) per the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  12. Intent to treat patient with both an anti-angiogenesis therapy (such as bevacizumab) and a PARP inhibitor as part of maintenance therapy. Only one or the other are permitted while the patient is on study and must be started between the baseline visit and Visit 1 if it will be used as part of the patient's maintenance therapy regimen.
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Please refer to this study by its identifier: NCT01521143

United States, California
LAC-USC Medical Center
Los Angeles, California, United States, 90033
United States, Florida
Collaborative Research Group
Boynton Beach, Florida, United States, 33435
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
University Gynecologic Oncology
Atlanta, Georgia, United States, 30342
United States, New Jersey
Women`s Cancer Center
Morristown, New Jersey, United States, 07962
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Greenslopes Private Hospital
Greenslopes, Australia
Royal Brisbane and Women`s Hospital
Herston, Australia
Sponsors and Collaborators
Prima BioMed Ltd
  More Information

Responsible Party: Prima BioMed Ltd Identifier: NCT01521143     History of Changes
Other Study ID Numbers: CAN-004 
Study First Received: January 17, 2012
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Prima BioMed Ltd:

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type processed this record on December 06, 2016