Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bavarian Nordic
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men and women ≥18 years old.
Patients must have histologically documented malignant tumor which is unresectable locally advanced or metastatic.
ECOG performance status 0 or 1
Patients must have normal organ and bone marrow function as defined in the protocol.
Normal left ventricular ejection fraction (LVEF) ≥50%.
Troponin I within normal limits.
A maximum cumulative dose of prior doxorubicin ≤360 mg/m2 or epirubicin ≤720 mg/m2
Any approved cancer therapy (except HER2 antibodies) must be completed at least 3 weeks or 5 half-lives for small molecule inhibitors, whichever is shorter, prior to the first planned dose of TVH vaccine.
HER-2 positive cancer: Patients are required to be on active treatment with HER2 antibodies (trastuzumab) prior to and during study treatment.
Chordoma patients with progressive extracranial chordoma (base of skull is permitted) not amenable for surgical resection with curative intent, nor for radiation therapy will be enrolled.
Patients must have recovered (Grade 1 or baseline) from any clinically significant toxicity associated with prior therapy.
Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1.
You may not be if
Known metastatic disease to the central nervous system, unless previously treated and responded with a minimum stable disease over 2 CT scans separated at least 4 weeks from each other, and more than 6 weeks since the last dose of dexamethasone.
History of allergy or untoward reaction to prior vaccination with vaccinia virus, aminoglycoside antibiotics, ciprofloxacin, or egg products.
Subjects should have no known evidence of being immunocompromised.
Chronic administration (defined as \>5 consecutive days of \>15 mg of prednisone (or equivalent) per day) of systemic corticosteroids within 14 days of the first planned dose of TAEK-VAC-HerBy vaccine. Use of inhaled steroids, nasal sprays, eye drops, and topical creams is allowed. Steroids premedication for CT scans is allowed.
Clinically significant cardiomyopathy, coronary disease, congestive heart failure (NYHA class III or IV) or reduced as per institutional standards LVEF, poorly controlled hypertension (systolic \>180 mm Hg or diastolic \>100 mm Hg) or cerebrovascular accident within 1 year.
Known history of, or any evidence of active, non-infectious pneumonitis or primary pulmonary fibrosis.
Clareo Health | TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer
