Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)

• ClinicalTrials.gov Identifier: NCT02111577
• Recruitment Status: Completed
• First Posted: April 11, 2014
• Last Update Posted: March 26, 2020
• Sponsor: Sotio a.s.
• Information provided by (Responsible Party): Sotio a.s.

Tracking Information

• First Submitted Date: April 9, 2014
• First Posted Date: April 11, 2014
• Last Update Posted Date: March 26, 2020
• Actual Study Start Date: April 2014
• Actual Primary Completion Date: December 19, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 10, 2014): Overall survival (all cause mortality) [ Time Frame: 124 Weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 10, 2014)

• Radiographic Progression Free Survival [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
• Duration to Prostate Specific Antigen (PSA) Progression [ Time Frame: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 weeks ]
• Duration to Skeletal Related Events [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 34, 38, 42, 46, 50, 54, 66, 78, 90, 102, 124 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
• Official Title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy
• Brief Summary: The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care Chemotherapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Metastatic Castrate Resistant Prostate Cancer

Intervention

• Biological: Dendritic Cells DCVAC
  DCVAC is the experimental therapy
• Biological: Placebo
  DCVAC placebo is experimental vaccine placebo
• Drug: Docetaxel
  Docetaxel and prednisone is Standard of Care First Line Chemotherapy
  Other Name: Taxotere
• Drug: Taxotere

Study Arms

• Experimental: DCVAC with Standard of Care Chemotherapy
  Combination therapy with Dendritic Cells DCVAC and Standard of Care Chemotherapy (Docetaxel and prednisone)
  Interventions:

  • Biological: Dendritic Cells DCVAC
  • Drug: Docetaxel
  • Drug: Taxotere
• Active Comparator: Standard of Care Chemo and Placebo
  Blinded combination therapy of Placebo and Standard of Care Chemotherapy (Docetaxel and prednisone) as Comparator
  Interventions:

  • Biological: Placebo
  • Drug: Docetaxel
  • Drug: Taxotere

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 25, 2020): 1182
• Original Estimated Enrollment (submitted: April 10, 2014): 1170
• Actual Study Completion Date: January 28, 2020
• Actual Primary Completion Date: December 19, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male 18 years and older
• Histologically or cytologically confirmed prostate adenocarcinoma
• Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis
• Disease progression despite Androgen Deprivation Therapy
• Maintenance of castrate conditions
• Life expectancy of at least 6 months based on Investigator´s judgment.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
• At least 4 weeks after surgery or radiotherapy
• A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy
• Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

• Confirmed brain and/or leptomeningeal metastases
• Current symptomatic cord compression requiring surgery or radiation therapy
• Prior chemotherapy for prostate cancer
• Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone)
• Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent for any reason other than treatment of prostate cancer (PCa) within the previous 6 months
• Systemic immunosuppressive therapy for any reason
• Treatment with immunotherapy against PCa within the previous 6 months prior to randomization
• Clinically significant cardiovascular disease
• Active autoimmune disease requiring treatment
• Uncontrolled co-morbidities
• Participation in a clinical trial using experimental therapy within the last 4 weeks prior to randomization
• Participation in a clinical trial using immunological experimental therapy (e.g. monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6 months prior to randomization

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belarus, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, United Kingdom, United States
• Removed Location Countries: Czech Republic, Romania, Turkey

Administrative Information

• NCT Number: NCT02111577
• Other Study ID Numbers: SP005; 2012-002814-38 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Sotio a.s.
• Study Sponsor: Sotio a.s.
• Collaborators: Not Provided

Investigators

• Study Director: Andrea Viktorinova, MD; Sotio a.s.

• PRS Account: Sotio a.s.
• Verification Date: March 2020