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

Phase 1

Withdrawn

• Conditions: Breast Carcinoma
• Interventions: Biological: rVV-740CTA

• Registration Number: NCT03110445
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07
• Study Start: 2020-03
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rVV-740CTA vaccine	rVV-740CTA	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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