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.
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
Interventions
Drug | Synonyms | Arms |
---|
rVV-740CTA | | rVV-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
Name | Type | Description | Interventions |
---|
rVV-740CTA vaccine | Experimental | | |
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: | Withdrawn |
Lead Sponsor: | University Hospital, Basel, Switzerland |
Last Updated
February 7, 2020