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Trial record 1 of 1 for:    CAN-004
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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 is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Prima BioMed Ltd
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd
ClinicalTrials.gov Identifier:
NCT01521143
First received: January 17, 2012
Last updated: October 21, 2014
Last verified: October 2014

January 17, 2012
October 21, 2014
January 2012
July 2015   (final data collection date for primary outcome measure)
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
Progression-free survival (PFS) for maintenance treatment of patients with EOC in complete remission following first-line chemotherapy [ 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, assessed up to 156 weeks ] [ 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 8 weeks after baseline.
Complete list of historical versions of study NCT01521143 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 up to 156 weeks. ] [ Designated as safety issue: No ]
    Assess Cvac as compared to placbo for overall survival
  • Assessment of safety and tolerability of Cvac as compared to placebo [ 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 up to 156 weeks ] [ 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.
Not Provided
Not Provided
 
Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy or Second-Line Treatment
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Epithelial Ovarian Cancer
  • 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.
  • 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.
  • Placebo Comparator: Placebo (Part A - First Remission)
    Part A is closed to recruitment
    Intervention: Biological: Placebo
  • 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).
    Intervention: Biological: Cvac
  • No Intervention: Observational Standard of Care
    Part B - Second-line Remission
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
286
July 2019
July 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Study Administrator Canvas@primabiomed.com.au
United States,   Australia,   Belarus,   Belgium,   Bulgaria,   Germany,   Latvia,   Lithuania,   Poland,   Ukraine
 
NCT01521143
CAN-004
Yes
Prima BioMed Ltd
Prima BioMed Ltd
Not Provided
Not Provided
Prima BioMed Ltd
October 2014

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