Modified melanoma cell-line vaccine for people at high risk of recurrence or with a small amount of remaining disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 trial gives an A2/4-1BBL melanoma vaccine — a compatible melanoma cell line engineered to express the costimulatory molecule 4-1BBL — to patients who are disease-free after surgery or have minimal residual disease but face high recurrence risk. Cells are DNP-sensitized before administration and patients may receive low-dose cyclophosphamide to modulate the immune response, with enrollment restricted to patients carrying specific HLA alleles to ensure antigen compatibility. The approach aims to stimulate tumor-directed T cell responses against residual tumor cells by increasing recognition of tumor antigens presented by the vaccine cell line. The trial is run at Hadassah Medical Organization in Jerusalem and includes dose-escalation and early efficacy/safety cohorts.

Why it matters

Who can join: the full rules

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

Where it's running

• Sharett Institute of Oncology, Hadassah Medical Organization
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Hani Steinberg, RN
• Email: hanis@hadassah.org.il
• Phone: 972507874292

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Social prescriptions and micro-learning to improve cancer care

  This study tests a multicomponent program using social prescriptions and short online learning to help cancer patients and their chosen support persons in Germany.

  Recruiting University of Regensburg · Augsburg, Bavaria and 7 other locations · NCT07788729

• TCC1727 combined with other cancer medicines for adults with advanced solid tumors

  This phase Ib/II trial tests TCC1727 given with benmelstobart, olaparib, or topotecan in adults with advanced solid tumors to find safe doses and see if the combinations help control tumors.

  Recruiting Phase 1/2 Beijing Tide Pharmaceutical Co., Ltd · Beijing, Beijing Municipality and 2 other locations · NCT07371663

• Regular supervised exercise to reduce symptoms in melanoma

  This trial tests whether a 12-week supervised exercise program can reduce fatigue and improve quality of life for adults with stage IIb–IV melanoma who are receiving immunotherapy or targeted therapy.

  Recruiting Universität Duisburg-Essen · Essen · NCT06985056

• Video consultations for cancer treatment recommendations

  This study is testing if video consultations can help patients with malignant melanoma get better treatment recommendations by connecting them with cancer experts from different specialties, no matter where they live.

  Recruiting University Hospital Muenster · Bonn and 2 other locations · NCT06980740

• Testing a new antibody treatment for advanced solid tumors and liver cancer

  This study is testing a new antibody treatment for people with advanced solid tumors and liver cancer to see if it is safe and how well it works.

  Recruiting at 5 sites Phase 1 Chiome Bioscience Inc. · Kashiwa, Chiba and 4 other locations · NCT06636435

• Using PSMA-PET to guide melanoma surgery planning

  We will see if a PSMA PET/CT scan can find melanoma spread more clearly than the standard FDG PET/CT in adults with palpable lymph nodes or limited metastatic melanoma who are scheduled for surgery.

  Recruiting Phase 2 Royal Marsden NHS Foundation Trust · London · NCT06560905

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.