OncoMatch

OncoMatch/Clinical Trials/NCT01898039

Modified Vaccine for High Risk or Low Residual Melanoma Patients

Is NCT01898039 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including A2/4-1BBL melanoma vaccine and Cyclophosphamide for malignant melanoma.

Phase 1/2RecruitingHadassah Medical OrganizationNCT01898039Data as of May 2026

Treatment: A2/4-1BBL melanoma vaccine · CyclophosphamideThis 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Biomarker criteria

Allowed: BRAF v600e

Allowed: BRAF wild-type

Disease stage

Required: Stage IIB, IIC, III, IV

Prior therapy

Min 2 prior lines

Must have received: chemotherapy (DTIC, temodal, taxanes, platinum compounds)

at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds)

Must have received: anti-CTLA-4 therapy (ipilimumab)

anti-CTLA-4 (ipilimumab)

Must have received: BRAF inhibitor

B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor

Cannot have received: cytotoxic drugs

Exception: if administered less than 28 days prior to protocol administration

Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration

Cannot have received: extensive radiotherapy

Exception: if administered less than 28 days prior to protocol administration

Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration

Lab requirements

Blood counts

hematocrit >25% and wbc >3000

Cardiac function

no active cardio-respiratory disease

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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