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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03110445
Collaborator
(none)
0
Enrollment
1
Arm
18
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: rVV-740CTA
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. number of adverse Events [2 years]

    Safety measured by assessment of number of adverse events that have occured

  2. number of serious adverse Events [2 years]

    Safety measured by assessment of number of serious adverse Events that have occured

Secondary Outcome Measures

  1. 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.

  2. Disease free survival [2 years]

    number of patients with no relapse of disease at timepoint 2 years

  3. Overall survival [2 years]

    number of patients still living at timepoint 2 years

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03110445
Other Study ID Numbers:
  • EKNZ 2015-026
First Posted:
Apr 12, 2017
Last Update Posted:
Feb 7, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vaccinia
Breast Neoplasms

Study Results

No Results Posted as of Feb 7, 2020