Clinical Trials /

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

NCT03110445

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: EKNZ 2015-026
  • NCT ID: NCT03110445

Conditions

  • Breast Carcinoma

Interventions

DrugSynonymsArms
rVV-740CTArVV-740CTA vaccine

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
rVV-740CTA vaccineExperimental
  • rVV-740CTA

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:number of adverse Events
Time Frame:2 years
Safety Issue:
Description:Safety measured by assessment of number of adverse events that have occured

Secondary Outcome Measures

Measure:Evolution of Immune reactivity to the CTA
Time Frame:18 months
Safety Issue:
Description:Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.
Measure:Disease free survival
Time Frame:2 years
Safety Issue:
Description:number of patients with no relapse of disease at timepoint 2 years
Measure:Overall survival
Time Frame:2 years
Safety Issue:
Description:number of patients still living at timepoint 2 years

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University Hospital, Basel, Switzerland

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