Actively Recruiting
Modified Vaccine for High Risk or Low Residual Melanoma Patients
Led by Hadassah Medical Organization · Updated on 2025-10-02
50
Participants Needed
1
Research Sites
726 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.
CONDITIONS
Official Title
Modified Vaccine for High Risk or Low Residual Melanoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have one or more of these tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, or -CW04/12(04/08)
- Cutaneous malignant melanoma stage IIb (>4 mm) or IIc (ulcerated melanoma >4 mm)
- Metastatic melanoma stage III after surgical removal of lymph nodes
- Metastatic melanoma stage IV that has been completely removed
- Non-resectable metastatic melanoma with low disease burden and normal LDH, having undergone at least two prior treatment lines including chemotherapy, anti-CTLA-4, and B-RAF inhibitor if applicable
- Non-cutaneous malignant melanoma including uveal and mucosal melanoma
- Melanoma may be mutant or wild-type B-RAF
- Karnofsky performance status over 80 (normal activity with effort)
- No active cardio-respiratory disease
- Not pregnant or nursing; women must use contraceptives during treatment
- Hematocrit over 25% and white blood cell count over 3000
- Patient must provide informed consent
You will not qualify if you...
- Cytotoxic drugs or extensive radiotherapy administered less than 28 days before study treatment
- Active brain metastases requiring corticosteroids
- Concurrent malignancy other than skin cancer, cervical carcinoma in situ, or early stage prostate cancer
- Active serious infection
- Allergy to penicillin
- Patient chooses to withdraw from the study at any time
- HIV infection or chronic hepatitis B or C carrier
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sharett Institute of Oncology, Hadassah Medical Organization
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
H
Hani Steinberg, RN
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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