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

Breast Carcinoma Clinical Trial

— rVV-740CTA  

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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03110445
• Other study ID #: EKNZ 2015-026
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2020
• Est. completion date: September 2021

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Vaccinia

Intervention

Biological:
• rVV-740CTA
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of adverse Events	Safety measured by assessment of number of adverse events that have occured	2 years
Primary	number of serious adverse Events	Safety measured by assessment of number of serious adverse Events that have occured	2 years
Secondary	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
Secondary	Disease free survival	number of patients with no relapse of disease at timepoint 2 years	2 years
Secondary	Overall survival	number of patients still living at timepoint 2 years	2 years