Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    CAN-004
Previous Study | Return to List | Next Study

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
  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 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.


Estimated Enrollment: 286
Study Start Date: January 2012
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521143

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

  Hide Study Locations
Locations
United States, California
Innovative Clinical Research Institute Withdrawn
Downey, California, United States, 90241
California Cancer Center Withdrawn
Greenbrae, California, United States, 94904
LAC-USC Medical Center Active, not recruiting
Los Angeles, California, United States, 90033
St Joseph Hospital Withdrawn
Orange, California, United States, 92868
University of California, San Francisco Withdrawn
San Francisco, California, United States, 94115
Stanford University School of Medicine Withdrawn
Stanford, California, United States, 94305
United States, Florida
Collaborative Research Group Active, not recruiting
Boynton Beach, Florida, United States, 33435
Sarasota Memorial Hospital Active, not recruiting
Sarasota, Florida, United States, 34239
United States, Georgia
University Gynecologic Oncology Active, not recruiting
Atlanta, Georgia, United States, 30342
Memorial Health University Medical Center Withdrawn
Savannah, Georgia, United States, 31404
United States, Illinois
University of Chicago Medical Center Withdrawn
Chicago, Illinois, United States, 60637
United States, New Jersey
Women`s Cancer Center Active, not recruiting
Morristown, New Jersey, United States, 07962
United States, Ohio
Cleveland Clinic Foundation Withdrawn
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University Withdrawn
Portland, Oregon, United States
Portland Medical Group Withdrawn
Portland, Oregon, United States, 97213
United States, Washington
Fred Hutchinson Cancer Research Center Active, not recruiting
Seattle, Washington, United States, 98109
Swedish Cancer Center Withdrawn
Seattle, Washington, United States, 98104
Australia
Royal Adelaide Hospital Withdrawn
Adelaide, Australia
Finders Medical Centre Withdrawn
Bedford Park, Australia
Greenslopes Private Hospital Active, not recruiting
Greenslopes, Australia
Royal Brisbane and Women`s Hospital Active, not recruiting
Herston, Australia
Launceston General Hospital Withdrawn
Launceston, Australia
Royal Women`s Hospital Withdrawn
Parkville, Australia
Belarus
Gomel Regional Clinical Oncological Dispensary Withdrawn
Gomel, Belarus
N.N. Alexandrov National Cancer Centre Recruiting
Minsk, Belarus
Belgium
ZNA Middleheim Recruiting
Antwerpen, Belgium
Brussels Saint-Luc University Hospital Withdrawn
Brussels, Belgium
Antwerpen University Hospital Recruiting
Edegem, Belgium
Ziekenhuis Oost Limburg Withdrawn
Genk, Belgium
University Hospital Brussel Recruiting
Jette, Belgium
CH Peltzer-La Tourelle Withdrawn
Verviers, Belgium
Sint Augustinus Hospital Withdrawn
Wilrijk, Belgium
UCL University Clinics of Mont Godinne Withdrawn
Yvoir, Belgium
Bulgaria
Univercity Multiprofile Hospital for Active Treatment `DrGeorgi Stranski, EAD Recruiting
Pleven, Bulgaria
`Complex Cancer Center Plovdiv` EOOD Recruiting
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD, Department of Medical Oncology Not yet recruiting
Plovdiv, Bulgaria, 4000
Multiprofile Hospital for Active Treatment `Tokuda Hospital Sofia`, AD Recruiting
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment for womens health- Nadezhda OOD, Clinic of Medical Oncology Not yet recruiting
Sofia, Bulgaria, 1330
Specialized Hospital for Active Treatment for Oncology EAD Recruiting
Sofia, Bulgaria
Univercity Multiprofile Hospital for Active Treatment Tzaritza Yoanna ISUL EAD Recruiting
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment `Sveta Marina` EAD Recruiting
Varna, Bulgaria
Comprehensive Cancer Centre Vratsa Recruiting
Vratsa, Bulgaria
Germany
University Hospital Bonn Active, not recruiting
Bonn, Germany
University Hospital Essen Active, not recruiting
Essen, Germany
University Hospital Heidelberg Active, not recruiting
Heidelberg, Germany
HELIOS Hospital Krefeld Active, not recruiting
Krefeld, Germany
Hospital St Georg gGmbH Not yet recruiting
Leipzig, Germany
Technical University Muenchen Not yet recruiting
Muenchen, Germany
Elbland Riesa Grossenhain Hospital eGmbH Not yet recruiting
Riesa, Germany
University Hospital Tuebingen Withdrawn
Tuebingen, Germany
Latvia
Daugavpils Regional Hospital Recruiting
Daugavpils, Latvia
Piejuras Hospital Recruiting
Liepaja, Latvia
Riga East Clinical University Hospital Recruiting
Riga, Latvia
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Recruiting
Kaunas, Lithuania
Institute of Oncology, Vilnius University Withdrawn
Vilnius, Lithuania
Vilnius University Hospital Santariskiu Clinics Recruiting
Vilnius, Lithuania
Poland
Bialystok Oncology Center, Specialist Oncology Hospital Not yet recruiting
Bialystok, Poland
Medical Univesity of Gdansk, Academic Clinical Centre Not yet recruiting
Gdansk, Poland
Oncology Centre of Gdynia Withdrawn
Gdynia, Poland
Maria SklodowskaCurie Memorial Cancer Center and Institute of Oncology, Krakow Branch Withdrawn
Krakow, Poland
M Kopernik Hospital in Lodz, Regional Centre of Oncology Withdrawn
Lodz, Poland
Medical University of Lublin Not yet recruiting
Lublin, Poland
Poznan University of Medical Scieneces, University Hospital of Lord`s Transfiguration Not yet recruiting
Poznan, Poland
Greater Poland Cancer Centre Not yet recruiting
Poznan, Poland
Ukraine
Municipal Institution of Cherkassy Regional Council, `Cherkassy Regional Oncology Dispensary` Recruiting
Cherkassy, Ukraine
Municipal Institution of City Clinical Hospital number4, Dnepropetrovsk State Medical Academy Active, not recruiting
Dnipropetrovsk, Ukraine
Municipal Clinical Healthcare Institution `Donetsk Regional AntiTumor Centre` Active, not recruiting
Donetsk, Ukraine
Ivano-Frankivsk Regional Oncology Clinical Centre, Chemotherapy Department Withdrawn
Ivano-Frankivsk, Ukraine
Kharkiv Regional Clinical Oncology Centre, Kharkiv Medical Academy of PostGraduate Education Active, not recruiting
Kharkiv, Ukraine
Kyiv City Clinical Oncology Centre Recruiting
Kyiv, Ukraine
Volyn Regional Oncology Dispensary Recruiting
Lutsk, Ukraine
Lviv State Regional Oncology Medical and Diagnostic Centre Recruiting
Lviv, Ukraine
Municipal Institution of Sumy Regional Clinical Oncology Dispensary Withdrawn
Sumy, Ukraine
Transcarpathian Regional Clinical Oncology Dispensary Recruiting
Uzhgorod, Ukraine
Sponsors and Collaborators
Prima BioMed Ltd
  More Information

No publications provided

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: October 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Prima BioMed Ltd:
EOC

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

ClinicalTrials.gov processed this record on November 27, 2014