Breast CarcinomaPhase 1rVV-740CTANCT03110445
Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
A Phase 1 study testing rVV-740CTA in people with Breast Carcinoma, run by University Hospital, Basel, Switzerland.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- rVV-740CTA
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of anaphylaxis or severe allergic reaction
- Severe heart, lung, kidney, liver or psychiatric condition
- Concurrent immunosuppressive therapy or impaired immune system
About this study
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.
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.
- Conditions
- Breast Carcinoma
- Being tested
- rVV-740CTA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVV-740CTABiological
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)
| Study group | Role | What they receive |
|---|---|---|
| rVV-740CTA vaccine | Experimental | Not described Receives: Biological: rVV-740CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of adverse Events
Safety measured by assessment of number of adverse events that have occured
Measured: 2 years
number of serious adverse Events
Safety measured by assessment of number of serious adverse Events that have occured
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 18 months
Disease free survival
number of patients with no relapse of disease at timepoint 2 years
Measured: 2 years
Overall survival
number of patients still living at timepoint 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startMar 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: not sufficiently staff available to perform trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul ZAJAC, PhD, Study director, University Hospital Basel - Dept of BiomedicineWalter WEBER, MD, Principal investigator, University Hospital of Basel - Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110445
- Sponsor's protocol ID
- EKNZ 2015-026
- Acronym
- rVV-740CTA
- Status last verified
- Feb 2020
- First submitted
- 11 May 2016
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publication per reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03110445
- Acronym / sponsor ID
- rVV-740CTA / EKNZ 2015-026
- Conditions
- Breast Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not sufficiently staff available to perform trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rVV-740CTA vaccine | Experimental | Biological: rVV-740CTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- History of anaphylaxis or severe allergic reaction
- Severe heart, lung, kidney, liver or psychiatric condition
- Concurrent immunosuppressive therapy or impaired immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rVV-740CTAnon replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L) | Biological | rVV-740CTA vaccine |
Primary outcome
number of adverse Events
Time frame: 2 years
Safety measured by assessment of number of adverse events that have occured
number of serious adverse Events
Time frame: 2 years
Safety measured by assessment of number of serious adverse Events that have occured
3 secondary outcomes
Evolution of Immune reactivity to the CTA
Time frame: 18 months
Disease free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No. publication per reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul ZAJAC, PhD study director
University Hospital Basel - Dept of Biomedicine
Walter WEBER, MD principal investigator
University Hospital of Basel - Dept of Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rVV-740CTA in people with Breast Carcinoma, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.