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

NCT ID: NCT03110445

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rVV-740CTA vaccine

Group Type EXPERIMENTAL

rVV-740CTA

Intervention Type BIOLOGICAL

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

Interventions

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rVV-740CTA

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul ZAJAC, PhD

Role: STUDY_DIRECTOR

University Hospital Basel - Dept of Biomedicine

Walter WEBER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Basel - Dept of Surgery

Other Identifiers

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EKNZ 2015-026

Identifier Type: -

Identifier Source: org_study_id

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