NCT01898039 Modified Vaccine for High Risk or Low Residual Melanoma Patients
| NCT ID | NCT01898039 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hadassah Medical Organization |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2013-05 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2013-05 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Cutaneous malignant melanoma AJCC stage IIb (\>4 mm) or IIc (ulcerated melanoma \>4mm). 3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes. 4. Metastatic melanoma AJCC stage IV, completely resected. 5. 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. 6. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma. 7. Melanoma can be of either mutant or wild-type B-RAF. 8. Karnofsky performance status \> 80 (Normal activity with effort). 9. No active cardio-respiratory disease. 10. Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit \>25% and WBC \>3000. 11. Informed consent of the patient. Exclusion Criteria: 1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration. 2. Active brain metastases requiring corticosteroids. 3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer). 4. Active serious infection. 5. Allergy to penicillin. 6. Patient's will to withdraw from the study at any stage. 7. HIV and chronic hepatitis B and C carrier
Contact & Investigator
Frequently Asked Questions
Who can join the NCT01898039 clinical trial?
This trial is open to participants of all sexes, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01898039 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01898039 currently recruiting?
Yes, NCT01898039 is actively recruiting participants. Contact the research team at hanis@hadassah.org.il for enrollment information.
Where is the NCT01898039 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT01898039 clinical trial?
NCT01898039 is sponsored by Hadassah Medical Organization. The trial plans to enroll 50 participants.
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