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.
Verified February 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: February 5, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Epithelial Ovarian Cancer
Biological: Placebo Study Agent
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: A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy (Australia and United States) / A Randomized Trial of Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-Line Chemotherapy or Following Second-Line Treatment (EU and EEU)

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 up to 156 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, 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 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 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.


Estimated Enrollment: 350
Study Start Date: January 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo (First-Line Chemotherapy - Closed to recruitment) Biological: Placebo Study Agent
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 (or SOC)
Cvac as compared with placebo for the maintenance treatment of patients with EOC in CR following first line chemotherapy
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: Standard of Care (second-line treatment)
Patients will be under observation, no anti-cancer maintenance treatment will be given to this group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Part B):

  • Females ≥ 18 years of age at screening with a confirmed first diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Have undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor
  • Underwent standard platinum and taxane first-line chemotherapy before relapse and had a CR for at least 6 months prior to relapse
  • Relapsed once and underwent either surgery and/or standard platinum and taxane second line chemotherapy
  • In CR, defined as CA-125 < ULN and no radiological evidence of disease
  • Life expectancy ≥ 3 months in the opinion of the investigator
  • Signed an ICF
  • Willing and able to complete study procedures within the study timelines
  • Mucin 1-positive tumor as determined by central immunohistopathology
  • Histologically or cytologically documented invasive EOC, primary peritoneal cancer, or fallopian tube cancer (patients with pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, patients with low malignant potential tumors, and with clear cell or mucinous histology are excluded)
  • Adequate end-organ and hematological function in the opinion of the investigator
  • 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 permitted
  • 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.

Inclusion Criteria (Part A):

  • Females ≥ 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Have undergone or will undergo optimal debulking surgery, defined as ≤ 1 cm of residual tumor
  • Eligible for, and plan to undergo standard platinum and taxane first-line chemotherapy
  • Signed an ICF
  • Willing and able to complete study procedures within the study timelines
  • Mucin 1-positive tumor as determined by central immunohistopathology
  • Adequate renal function in the opinion of the investigator based on serum creatinine and/or glomerular filtration rate
  • Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) ≤ 2 × upper limit of normal (ULN) and serum bilirubin ≤ 1.5 × ULN unless Gilbert's syndrome has previously been confirmed for the patient.
  • 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
  • Life expectancy of at least 12 months at the time of screening as judged by the investigator
  • 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.

Exclusion Criteria (Part B):

  • More than 3 previous regimens of anticancer therapy for EOC, primary peritoneal, or fallopian tube cancer
  • Primary platinum-refractory or platinum-resistant disease
  • Treatment with any investigational product (for any condition) within 4 weeks of screening
  • Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
  • 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
  • Diagnosed immunodeficiency or autoimmune disorder
  • Infection with HIV or HCV, or active and infectious HBV infection
  • Pregnant or lactating
  • Evidence or history of central nervous system metastasis
  • Known hypersensitivity to any of the components of the study agent
  • Enrolled in or has not completed at least 30 days (prior to randomization) since ending other investigational device or drug treatment, or currently receiving other investigational treatments
  • Unresolved toxicities from prior systemic therapy that are Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 ≥ Grade 2 in severity except for alopecia

Exclusion Criteria (Part A):

  • Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Müllerian tumors, or mucinous carcinoma of the peritoneum
  • Malignancy other than EOC, except those that have been in CR for a minimum of 3 years, and except carcinoma in-situ of the cervix or basal cell and squamous cell carcinomas of the skin that have been adequately treated
  • Treatment with any investigational product (for any condition) within 4 weeks of screening
  • Concurrent systemic treatment with steroids or other immunosuppressant agents at a dose considered by the investigator to be higher than a standard physiological dose
  • 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
  • Clinically significant abnormalities as measured by ECG
  • Active uncontrolled infection
  • Uncontrolled hypertension
  • Diagnosed immunodeficiency or autoimmune disorder
  • Infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or active and infectious hepatitis B virus (HBV) infection
  • Pregnant or lactating
  • Evidence or history of central nervous system metastasis
  • Known hypersensitivity to any of the components of the study agent
  • Active or latent infection with Mycobacterium tuberculosis in any body tissue (especially renal and/or lung)
  • Any other health condition that would preclude participation in the study in the judgment of the principal investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521143

Contacts
Contact: Study Administrator Canvas@primabiomed.com.au

  Show 72 Study Locations
Sponsors and Collaborators
Prima BioMed Ltd
  More Information

Publications:
Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01521143     History of Changes
Other Study ID Numbers: CAN-004
Study First Received: January 17, 2012
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Prima BioMed Ltd:
EOC

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014