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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Biological: rVV-740CTA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rVV-740CTA vaccine<br> | Biological: rVV-740CTA<br>* non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse Events | Safety measured by assessment of number of adverse events that have occured | 2 years | 
| number of serious adverse Events | Safety measured by assessment of number of serious adverse Events that have occured | 2 years | 

Secondary Outcome Measures

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