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Modified Vaccine for High Risk or Low Residual Melanoma Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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.

NCT01898039•Hadassah Medical Organization

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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

Locations (1)

Sharett Institute of Oncology, Hadassah Medical Organization

Jerusalem, Israel

Key Dates

Start Date

May 1, 2013

Primary Completion Date

April 1, 2027

Completion Date

April 1, 2027

Last Updated

October 2, 2025

Enrollment

ESTIMATED participants

Conditions

Malignant Melanoma

Interventions

A2/4-1BBL melanoma vaccine

BIOLOGICAL

DNP sensititzation

PROCEDURE

Cyclophosphamide

DRUG

Contacts

Hani Steinberg, RN

CONTACT

972507874292 hanis@hadassah.org.il

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

NCT07371663

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

AMT-253 in Patients With Advanced Solid Tumours

NCT06209580

Malignant MelanomaAdvanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Modified Vaccine for High Risk or Low Residual Melanoma Patients

Inclusion Criteria

Exclusion Criteria

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

AMT-253 in Patients With Advanced Solid Tumours

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