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

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.

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03110445

Acronym

rVV-740CTA

Enrollment

Registered

2017-04-12

Start date

2020-03-31

Completion date

2021-09-30

Last updated

2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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.

Interventions

BIOLOGICALrVV-740CTA

non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
number of adverse Events	2 years	Safety measured by assessment of number of adverse events that have occured
number of serious adverse Events	2 years	Safety measured by assessment of number of serious adverse Events that have occured

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026