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not sufficiently staff available to perform trial
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rVV-740CTA vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rVV-740CTA | Biological | non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul ZAJAC, PhD | University Hospital Basel - Dept of Biomedicine | Study Director |
| Walter WEBER, MD | University Hospital of Basel - Dept of Surgery | Principal Investigator |
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publication per reviewed journal
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |