High Risk HLA-A2+ MelanomaPhase 2/3NCT01861938
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients
A Phase 2/3 study testing Melanoma vaccine modified to express HLA A2/4-1BB ligand in people with High Risk HLA-A2+ Melanoma and Metastatic Disease, run by Hadassah Medical Organization.
Trial summary
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Risk HLA-A2+ Melanoma, Metastatic Disease
- What is being tested?
- Melanoma vaccine modified to express HLA A2/4-1BB ligand
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Mar 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 (over 4 mm) or IIc (ulcerated melanoma over 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 cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
- Melanoma can be of either mutant or wild-type B-RAF.
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- Karnofsky performance status over 80 (Normal activity with effort).
- No active cardio-respiratory disease.
- Hematocrit over 25% and WBC over 3000.
- Informed consent of the patient.
Who cannot join
- Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- Active brain metastases requiring cortico-steroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- Active serious infection.
- Allergy to penicillin.
- Patient's wish to withdraw from the study at any stage.
About this study
Official title: Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.
- Conditions
- High Risk HLA-A2+ Melanoma, Metastatic Disease
- Being tested
- Melanoma vaccine modified to express HLA A2/4-1BB ligand
- Keywords
- melanoma, vaccine, Resectable AJCC stage IV, AJCC stages IIb-c, III, Patients with low-burden, failed, respond, one treatment line
- Medical subject headings
- Neoplasm Metastasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanoma vaccine modified to express HLA A2/4-1BB ligandBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma vaccine | Experimental | Not described Receives: Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse effects
Measured: For 20 weeks from the start of treatment
Secondary outcomes (1)
Overall and disease free survival
Measured: For at least five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMar 2017 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: The study was withdrawn because no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk HLA-A2+ MelanomaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861938
- Sponsor's protocol ID
- 0419-12-HMO
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2012
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
- ClinicalTrials.gov ID
- NCT01861938
- Acronym / sponsor ID
- 0419-12-HMO
- Conditions
- High Risk HLA-A2+ Melanoma, Metastatic Disease
- Keywords
- melanoma, vaccine, Resectable AJCC stage IV, AJCC stages IIb-c, III, Patients with low-burden, failed, respond, one treatment line
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn because no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma vaccine | Experimental | Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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 (over 4 mm) or IIc (ulcerated melanoma over 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 cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
Key exclusion criteria (6 listed)
- Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- Active brain metastases requiring cortico-steroids.
- Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- Active serious infection.
- Allergy to penicillin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanoma vaccine modified to express HLA A2/4-1BB ligandThis 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. | Biological | Melanoma vaccine |
Primary outcome
Number of adverse effects
Time frame: For 20 weeks from the start of treatment
1 secondary outcome
Overall and disease free survival
Time frame: For at least five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melanoma vaccine modified to express HLA A2/4-1BB ligand in people with High Risk HLA-A2+ Melanoma and Metastatic Disease, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse effects (time frame: For 20 weeks from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.