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

February 5, 2020 updated by: University Hospital, Basel, Switzerland

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.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rVV-740CTA vaccine
Biological: rVV-740CTA
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Director: Paul ZAJAC, PhD, University Hospital Basel - Dept of Biomedicine
  • Principal Investigator: Walter WEBER, MD, University Hospital of Basel - Dept of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2015-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

publication per reviewed journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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