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Also known as Recombinant MAGE-A3 Protein, MAGE-A3, MAGE-A3 ASCI
recMAGE-A3+ AS15 · 2 trials · 2 indications
To evaluate the objective response rate induced by the concurrent administration of HDIL-2 and recMAGE-A3 + AS15 ASCI in patients with MAGE-A3-positive, unresectable or metastatic melanoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| HDIL-2 + recMAGE-A3 + AS15 | EXPERIMENTAL | HDIL-2 720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle. recMAGE-A3 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2. |
| NMIBC at intermediate risk of progression | EXPERIMENTAL | - |
| NMIBC at high risk of progression | EXPERIMENTAL | - |
| NMIBC at low risk of progression | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HDIL-2 | DRUG | 720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle. |
| recMAGE-A3 + AS15 | BIOLOGICAL | 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2. |
| MAGE-A3 ASCI | BIOLOGICAL | 5 doses every 3 weeks |
| BCG | BIOLOGICAL | 1 intravesical dose /week for 6 weeks |
Inclusion Criteria: 1. STEP 1 Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. 2. Male or female patient with histologically proven, measurable unresectable or metastatic cutaneous melanoma 3. Patient is \>/= 18 years of age. 4. ...
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recMAGE-A3+ AS15 is an investigational cancer immunotherapy that was studied in melanoma. It combines the recombinant MAGE-A3 antigen with the AS15 adjuvant system and was evaluated in a Phase 2 trial in patients with melanoma, including in combination with high-dose interleukin-2.
recMAGE-A3+ AS15 was developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical research evaluating this agent in melanoma.
recMAGE-A3+ AS15 is in Phase 2 development. It is investigational and has been studied in a single completed Phase 2 clinical trial in melanoma; it is not described as an approved therapy.
recMAGE-A3+ AS15 has been studied in one Phase 2 trial, NCT01266603, titled High-Dose Interleukin-2 (HDIL-2), Combined With recMAGE-A3 + AS15 ASCI. The trial enrolled 44 patients with melanoma in the United States and is completed.
The Phase 2 trial NCT01266603 was an uncontrolled study with no randomized or double-blind design, enrolling 44 adults aged 18 years and older with melanoma. It evaluated recMAGE-A3 + AS15 ASCI given in combination with high-dose interleukin-2 and was conducted in the United States.