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

University Hospital Basel

Status and phase: Withdrawn; Phase 1

Conditions: Breast Carcinoma

Treatments: Biological: rVV-740CTA

Study type: Interventional

Funder types: Other

Identifiers

NCT03110445

EKNZ 2015-026

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

rVV-740CTA vaccine

Experimental group

Treatment:

Biological: rVV-740CTA