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Recruitment Status : Withdrawn (not sufficiently staff available to perform trial)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

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Biological: rVV-740CTA Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rVV-740CTA vaccine Biological: rVV-740CTA
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)




Primary Outcome Measures :
  1. number of adverse Events [ Time Frame: 2 years ]
    Safety measured by assessment of number of adverse events that have occured

  2. number of serious adverse Events [ Time Frame: 2 years ]
    Safety measured by assessment of number of serious adverse Events that have occured


Secondary Outcome Measures :
  1. 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.

  2. Disease free survival [ Time Frame: 2 years ]
    number of patients with no relapse of disease at timepoint 2 years

  3. Overall survival [ Time Frame: 2 years ]
    number of patients still living at timepoint 2 years



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110445


Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Study Director: Paul ZAJAC, PhD University Hospital Basel - Dept of Biomedicine
Principal Investigator: Walter WEBER, MD University Hospital of Basel - Dept of Surgery
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03110445    
Other Study ID Numbers: EKNZ 2015-026
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: publication per reviewed journal

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccinia
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections