NCT01898039RecruitingPhase 1/2
Modified Vaccine for High Risk or Low Residual Melanoma Patients
Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients - Phase I/II Study.
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 May 2013
- Start date
- May 2013
- Primary completion date
- Apr 2027
- Lead sponsor
- Hadassah Medical Organization
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT01898039
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From May 2013 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- Active brain metastases requiring corticosteroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
Other illness
- Active serious infection.
- Allergy to penicillin.
- HIV and chronic hepatitis B and C carrier
Other
- Patient's will to withdraw from the study at any stage.
Who the study is looking for
- Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
- Cutaneous malignant melanoma AJCC stage IIb (\>4 mm) or IIc (ulcerated melanoma \>4mm).
- Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.
- Metastatic melanoma AJCC stage IV, completely resected.
- Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
- Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
- Melanoma can be of either mutant or wild-type B-RAF.
- Karnofsky performance status \> 80 (Normal activity with effort).
- No active cardio-respiratory disease.
- Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit \>25% and WBC \>3000.
- Informed consent of the patient.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sharett Institute of Oncology, Hadassah Medical Organization Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.