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WithdrawnNCT03110445rVV-740CTAUpdated Feb 7, 2020

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

A Phase 1 interventional study of rVV-740CTA in Breast Carcinoma, sponsored by University Hospital, Basel, Switzerland. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by University Hospital, Basel, Switzerland · Phase 1, Interventional, and Treatment

Why this study was withdrawn
not sufficiently staff available to perform trial
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Breast Carcinoma
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In context

Vaccinia

73 studies on the registry are indexed under Vaccinia; 6 are open to participants now.

Browse Vaccinia studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • History of anaphylaxis or severe allergic reaction
  • Severe heart, lung, kidney, liver or psychiatric condition
  • Concurrent immunosuppressive therapy or impaired immune system
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    rVV-740CTA vaccine

    Biological: rVV-740CTA

Interventions

  • BiologicalrVV-740CTA

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

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What researchers measure

Primary outcomes

  1. number of adverse Events

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

    Time frame: 2 years

  2. number of serious adverse Events

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

    Time frame: 2 years

Secondary outcomes

  1. Evolution of Immune reactivity to the CTA

    Vaccine epitopes specific CD8+ T-cell responses will be evaluated from peripheral blood samples prior, during and after treatment.

    Time frame: 18 months

  2. Disease free survival

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

    Time frame: 2 years

  3. Overall survival

    number of patients still living at timepoint 2 years

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — publication per reviewed journal

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03110445
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Apr 12, 2017
Start date
Mar 2020 (estimated)
Primary completion
Sep 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Feb 7, 2020

Study contacts

Paul ZAJAC, PhD
study director · University Hospital Basel - Dept of Biomedicine
Walter WEBER, MD
principal investigator · University Hospital of Basel - Dept of Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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