Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

Last updated: September 29, 2025
Sponsor: Hadassah Medical Organization
Overall Status: Trial Not Available

Phase

2/3

Condition

Metastatic Cancer

Melanoma

Neoplasm Metastasis

Treatment

Melanoma vaccine modified to express HLA A2/4-1BB ligand

Clinical Study ID

NCT01861938
0419-12-HMO
  • All Genders

Study 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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients included in this protocol must carry one or more of the following tissuetyping 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 (over 4 mm) or IIc (ulcerated melanomaover 4mm).

  3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgicalremoval of lymph nodes.

  4. Metastatic melanoma AJCC stage IV, completely resected.

  5. Non cutaneous malignant melanoma of respective stages including uveal and mucosalmelanoma.

  6. Melanoma can be of either mutant or wild-type B-RAF.

  7. Karnofsky performance status over 80 (Normal activity with effort).

  8. No active cardio-respiratory disease.

  9. Hematocrit over 25% and WBC over 3000.

  10. Informed consent of the patient.

Exclusion

Exclusion Criteria:

  1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days priorto protocol administration.

  2. Active brain metastases requiring cortico-steroids.

  3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and earlystage prostate cancer).

  4. Active serious infection.

  5. Allergy to penicillin.

  6. Patient's wish to withdraw from the study at any stage.

Study Design

Treatment Group(s): 1
Primary Treatment: Melanoma vaccine modified to express HLA A2/4-1BB ligand
Phase: 2/3
Study Start date:
March 01, 2017
Estimated Completion Date:
March 31, 2019