Actively Recruiting
FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition
Led by University Hospital Tuebingen · Updated on 2024-12-09
20
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in combination with anti-programmed cell death-ligand 1 immune checkpoint inhibition (ICI) by Atezolizumab (TecentriqTM) in patients with Fibrolamellar hepatocellular carcinoma (FL-HCC) or other cancer entities carrying the DNAJB1-PRKACA fusion transcript.
CONDITIONS
Official Title
FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Histologically confirmed FL-HCC or other malignant disease that is locally advanced or metastatic
- Non-FL-HCC patients included if disease progressed after therapy with no further standard options, unsuitable for available therapy, unwilling to receive standard therapy, or if no standard therapy exists
- Presence of DNAJB1-PRKACA fusion transcript confirmed by RNA-based NGS or RT-PCR
- Age 18 years or older
- ECOG performance status 0 or 1
- Measurable disease per iRECIST criteria
- Negative SARS-CoV-2 rapid antigen test if WHO declares pandemic
- Adequate organ function including lymphocyte count >500/µl, platelets >50,000/µl, creatinine clearance >30 ml/min, Child-Pugh class A or B7 liver function, ALT/AST ≤5 times upper limit, bilirubin ≤3 mg/dl
- Negative Hepatitis B serology or PCR if positive without active infection, negative Hepatitis C RNA, negative HIV test within 6 weeks prior to inclusion
- Females of childbearing potential and male patients with partners of childbearing potential must use two effective contraception methods from consent until 5 months after last treatment dose
- Two negative pregnancy tests for females of childbearing potential prior to first vaccination
- Postmenopausal women or evidence of non-childbearing status
You will not qualify if you...
- Pregnant or breastfeeding
- Unwilling or unable to follow study schedule
- Chemotherapy, systemic therapy, or radiotherapy within 14 days before first dose
- Participation in other interventional clinical trials with investigational therapy within 30 days prior
- Major surgery within 28 days before dosing
- Not recovered from prior adverse events to grade ≤2 except alopecia and neurotoxicity
- History of severe autoimmune reactions from immunotherapy (grade ≥3)
- Immunotherapy treatment within 28 days before dosing
- Live vaccine within 28 days before study treatment
- Known allergy or hypersensitivity to investigational drugs or related products
- History of severe allergic anaphylaxis to chimeric, human, or humanized antibodies or fusion proteins
- Active autoimmune disease requiring or having required systemic immunosuppressive treatment in past 2 years
- Presence of any tissue or organ transplant including corneal allograft
- History of allogeneic hematopoietic stem cell transplant
- Diagnosis of immunodeficiency
- Systemic corticosteroids (>10 mg prednisone equivalent) or other immunosuppressives within 7 days before dosing
- Symptomatic interstitial lung disease
- Active or untreated brain metastases or leptomeningeal metastases
- Uncontrolled illnesses including infection, heart failure, unstable angina, arrhythmia, other metastatic cancer, or psychiatric/social issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Baden-Würtemberg, Germany, 72076
Actively Recruiting
Research Team
J
Juliane Walz, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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