Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D1/3-MAGE-3-His fusion protein | Biological | — | UNRESOLVED |
| SB-AS02B adjuvant | Biological | — | UNRESOLVED |
| SB-AS15 adjuvant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response rate (complete response and partial response) as assessed by RECIST criteria
- measure
- Vaccine-related toxicity as assessed by CTCAE v3
Secondary outcomes (4)
- measure
- Rate of stabilization as assessed by RECIST criteria
- measure
- Rate of mixed response as assessed by RECIST criteria
- measure
- Rate of immune response
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous melanoma * Unresectable stage III OR stage IV M1a disease * Documented progressive disease within the past 12 weeks * Measurable disease * Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery * Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay) * No visceral metastases within the past 56 days by imaging PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ lower limit of normal (LLN) * WBC ≥ LLN * Lymphocyte count ≥ LLN * Platelet count ≥ LLN * No bleeding disorders Hepatic * Bilirubin ≤ upper limit of normal (ULN) * Lactic dehydrogenase ≤ ULN * AST and ALT ≤ 2 times ULN * PT and aPTT normal * Hepatitis B surface antigen negative (antibody test may be positive) * Hepatitis C antibody negative Renal * Creatinine ≤ ULN Cardiovascular * No clinically significant heart disease (CTC grade III or IV) Immunologic * No autoimmune disease (vitiligo allowed) * No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens * No immunodeficiency * No active infection requiring antibiotic therapy * HIV negative Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other serious acute or chronic illness requiring concurrent medications * No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 8 weeks since prior adjuvant vaccine therapy * No prior vaccine therapy containing a MAGE-3 antigen * No prior vaccine therapy for metastatic melanoma * No concurrent immunomodulating agents (e.g., BCG) Chemotherapy * No prior systemic chemotherapy * No concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids * Concurrent prednisone or equivalent allowed provided the dose is ≤ 40 mg/day and treatment duration is for no more than 3 weeks * Concurrent inhaled and topical steroids are allowed Radiotherapy * No prior radiotherapy to the spleen * No concurrent radiotherapy to \> 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions) * Concurrent local low-dose (≤ 20 Grays) radiotherapy allowed Surgery * Recovered from prior surgery or biopsy * No prior organ allograft * No prior splenectomy * Concurrent surgery to a limited number of lesions allowed for patients with a complete response, partial response, or stable disease after at least 3 courses of study therapy Other * No prior systemic anticancer therapy * More than 4 weeks since prior isolated limb perfusion therapy * No other concurrent anticancer therapy * No other concurrent immunosuppressive agents
References
Publications (4)
- RESULTKruit WH, Suciu S, Dreno B, et al.: Immunization with recombinant MAGE-A3 protein combined with adjuvant systems AS15 or AS02B in patients with unresectable and progressive metastatic cutaneous melanoma: A randomized open-label phase II study of the EORTC Melanoma Group (16032- 18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9065, 2008.
- RESULTLouahed J, Gruselle O, Gaulis S, et al.: Expression of defined genes identified by pretreatment tumor profiling: association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032-18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9045, 2008.
- DERIVEDKruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol. 2013 Jul 1;31(19):2413-20. doi: 10.1200/JCO.2012.43.7111. Epub 2013 May 28. PMID 23715572
- DERIVEDUlloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28. PMID 23715562