Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus (rVV-740CTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110445
Recruitment Status : Withdrawn (not sufficiently staff available to perform trial)
First Posted : April 12, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE April 12, 2017
Last Update Posted Date February 7, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • number of adverse Events [ Time Frame: 2 years ]
    Safety measured by assessment of number of adverse events that have occured
  • number of serious adverse Events [ Time Frame: 2 years ]
    Safety measured by assessment of number of serious adverse Events that have occured
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
Safety assessment of adverse events and serious adverse events [ Time Frame: 2 years ]
measured by assessment of adverse events and serious adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • Evolution of Immune reactivity to the CTA [ Time Frame: 18 months ]
    Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.
  • Disease free survival [ Time Frame: 2 years ]
    number of patients with no relapse of disease at timepoint 2 years
  • Overall survival [ Time Frame: 2 years ]
    number of patients still living at timepoint 2 years
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Evolution of Immune reactivity to the CTA [ Time Frame: 2 years ]
    Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.
  • Disease free survival [ Time Frame: 2 years ]
    number of patients with no relapse of disease at timepoint 2 years
  • Overall survival [ Time Frame: 2 years ]
    number of patients still living at timepoint 2 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
Official Title  ICMJE Monocentric Open Label Phase I Immunotherapy Trial of Breast Cancer Patients With a Non-replicating Recombinant Vaccinia Virus Expressing Cancer/Testis Antigens and Cluster of Differentiation Antigen 80 (CD80)-CD40L Costimulatory Molecules.
Brief Summary Monocentric open-label phase I/II trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (CTA) derived epitopes and CD80 and CD40 ligand (CD40L, CD154) costimulatory molecules in patients with CTA expressing tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Carcinoma
Intervention  ICMJE Biological: rVV-740CTA
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)
Study Arms  ICMJE Experimental: rVV-740CTA vaccine
Intervention: Biological: rVV-740CTA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 5, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2017)
15
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Surgically treated M0 patients with solid tumors
  • Tumor expressing at least one of the vaccine targeted antigens Melanoma-associated antigen (MAGE)-A1, -A2,
  • A3, -A4, -A6, -A10, -A12 or New York (NY) esophageal squamous cell carcinoma-1 (ESO-1) (NY-ESO-1) (by real-time quantitative PCR (RT-qPCR))
  • Patient expressing the targeted Human Leukocyte Antigen (HLA) restriction (A0201 /A0101/ B3501)
  • 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
  • Karnofsky over 70%
  • No other concomitant malignancy

Exclusion Criteria:

  • History of anaphylaxis or severe allergic reaction
  • Severe heart, lung, kidney, liver or psychiatric condition
  • Concurrent immunosuppressive therapy or impaired immune system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03110445
Other Study ID Numbers  ICMJE EKNZ 2015-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: publication per reviewed journal
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul ZAJAC, PhD University Hospital Basel - Dept of Biomedicine
Principal Investigator: Walter WEBER, MD University Hospital of Basel - Dept of Surgery
PRS Account University Hospital, Basel, Switzerland
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP