Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment

NCT01521143 | Terminated Phase 2 Results DMC

• 1 other identifier: CAN-004
• Study Type: interventional
• Target: 91
• Locations: 2 countries
• Sites: 8

Brief Summary

As \< 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of \< 10%. The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.

Conditions

Epithelial Ovarian Cancer

Keywords

EOC

Outcome Measures

Primary Outcomes (1)

• Part A - Overall Survival

  Overall survival was defined as the number of days from Baseline to the date of death from any cause.

  Baseline to the end of the study (up to 3 years, 2 months)

Secondary Outcomes (5)

• Part A - Time to Next Treatment

  Baseline to the end of the study (up to 3 years, 2 months)

• Part A - Progression-free Survival

  Baseline to the end of the study (up to 3 years, 2 months)

• Part B - Overall Survival

  Baseline to the end of the study (up to 3 years, 2 months)

• Part B - Time to Next Treatment

  Baseline to the end of the study (up to 3 years, 2 months)

• Part B - Progression-free Survival

  Baseline to the end of the study (up to 3 years, 2 months)

Study Arms (4)

Part A - Cvac

EXPERIMENTAL

Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.

Biological: Cvac

Part A - Placebo

PLACEBO COMPARATOR

Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.

Biological: Placebo

Part B - Cvac

EXPERIMENTAL

Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10\^6 viable dendritic cells/mL.

Biological: Cvac

Part B - Observational standard of care

NO INTERVENTION

Participants in this group did not receive any treatment during the study.

Interventions

Cvac BIOLOGICAL

Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.

Part A - Cvac; Part B - Cvac

Placebo BIOLOGICAL

Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs. Placebo consisted of the Cvac formulation buffer (5% HSA, 10% DMSO) with 0.9% simethicone provided in 1 mL vials that had been cryopreserved and stored at the manufacturing facility.

Part A - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥ 18 years of age at screening with a confirmed diagnosis of Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
• Undergone optimal debulking surgery, defined as ≤ 1 cm of residual tumor.
• Undergone standard platinum and taxane first-line chemotherapy.
• Signed an informed consent form (ICF).
• Completed 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, defined as 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, unless Gilbert's syndrome had been previously confirmed for the patient.
• Adequate bone marrow function, defined as 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, agreed 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.

You may not qualify if:

• Non-epithelial ovarian cancer, including ovarian germ cell, sarcoma, mixed Müllerian tumors, or mucinous carcinoma of the peritoneum.
• Malignancy other than epithelial ovarian cancer, except those that had been in complete response 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 had 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 electrocardiogram (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.

Sponsors & Collaborators

• Prima BioMed Ltd: lead

Study Sites (8)

LAC-USC Medical Center

Los Angeles, California, 90033, United States

Location

Collaborative Research Group

Boynton Beach, Florida, 33435, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University Gynecologic Oncology

Atlanta, Georgia, 30342, United States

Location

Women's Cancer Center

Morristown, New Jersey, 07962, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Greenslopes Private Hospital

Greenslopes, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Australia

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

CCV-AV protocol

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Marc Voigt
• Organization: Prima BioMed, Ltd.

marc.voigt@primabiomed.com.au

49 173 6771602

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 30, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 14, 2016
• Results First Posted: December 14, 2016

Record last verified: 2016-12

Locations

AU (2); US (6)