Study Stopped
not sufficiently staff available to perform trial
Cancer/Testis Antigen Immunotherapy Phase I Study With 740-CTA Vaccinia Virus
rVV-740CTA
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.
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFebruary 7, 2020
February 1, 2020
1.5 years
May 11, 2016
February 5, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
number of adverse Events
Safety measured by assessment of number of adverse events that have occured
2 years
number of serious adverse Events
Safety measured by assessment of number of serious adverse Events that have occured
2 years
Secondary Outcomes (3)
Evolution of Immune reactivity to the CTA
18 months
Disease free survival
2 years
Overall survival
2 years
Study Arms (1)
rVV-740CTA vaccine
EXPERIMENTALInterventions
non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)
Eligibility Criteria
You may qualify if:
- 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)
- weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy.
- Karnofsky over 70%
- No other concomitant malignancy
You may not qualify if:
- History of anaphylaxis or severe allergic reaction
- Severe heart, lung, kidney, liver or psychiatric condition
- Concurrent immunosuppressive therapy or impaired immune system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul ZAJAC, PhD
University Hospital Basel - Dept of Biomedicine
- PRINCIPAL INVESTIGATOR
Walter WEBER, MD
University Hospital of Basel - Dept of Surgery
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2016
First Posted
April 12, 2017
Study Start
March 1, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
publication per reviewed journal