Cvac as Maintenance Treatment in Patients With EOC in Complete Remission Following First-Line Chemotherapy - Full Text View

Purpose

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

Following surgery and study randomization, patients will undergo leukapheresis for manufacture of the study agent and then begin first-line chemotherapy. 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 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Prima BioMed Ltd:

Primary Outcome Measures:

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.

Secondary 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 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.

Estimated Enrollment:	1000
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Biological: Placebo Study Agent Study agent will be administered via intradermal injection, every 4 weeks for the first 3 doses and thereafter every 12 weeks for 3 additional doses
Active Comparator: Cvac 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.

Detailed Description:

This study proposes a nontoxic immunotherapeutic approach to extend the progression free interval following first-line treatment in patients in complete remission.

Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and 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. The ability to increase the progression-free intervals between chemotherapeutic treatments would have a significant benefit to a patient's quality of life and would potentially lead to longer overall survival.

Eligibility

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

Criteria

Inclusion Criteria:

A confirmed 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
Eligible for, and plan to undergo standard platinum and taxane first-line chemotherapy
Mucin 1-positive tumor as determined by central immunohistopathology
Adequate renal function
Adequate liver function
Adequate bone marrow function
Life expectancy of at least 12 months at the time of screening as judged by the investigator

Exclusion Criteria:

Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Mullerian 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
Evidence of severe or uncontrolled cardiac disease
Active uncontrolled infection
Uncontrolled hypertension
Diagnosed immunodeficiency or autoimmune disorder

Contacts and Locations

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

Contacts

Contact: Study Administrator

Canvas@primabiomed.com.au

Show 95 Study Locations

Sponsors and Collaborators

Prima BioMed Ltd

More Information

Publications:

Apostolopoulos V, Pietersz GA, McKenzie IF. Cell-mediated immune responses to MUC1 fusion protein coupled to mannan. Vaccine. 1996 Jun;14(9):930-8.

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.

Chi DS, Eisenhauer EL, Lang J, Huh J, Haddad L, Abu-Rustum NR, Sonoda Y, Levine DA, Hensley M, Barakat RR. What is the optimal goal of primary cytoreductive surgery for bulky stage IIIC epithelial ovarian carcinoma (EOC)? Gynecol Oncol. 2006 Nov;103(2):559-64. Epub 2006 May 22.

Katsumata N, Yasuda M, Takahashi F, Isonishi S, Jobo T, Aoki D, Tsuda H, Sugiyama T, Kodama S, Kimura E, Ochiai K, Noda K; Japanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1331-8. Epub 2009 Sep 18.

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:	June 3, 2013
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 June 17, 2013

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