Clinical trial · Interventional
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
A Randomized Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC in Patients With Resected MAGE-A3 Positive, Stage IV Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Treatment Ineffective
Summary
Brief summary (as posted)
The overall purpose of this research study is to find a better way to treat melanoma. The goals of this study are: 1. To measure the side effects of and find out how well patients tolerate the recMAGE-A3 + AS15 ASCI (MAGE-A3 ASCI) treatment with or without the Poly IC:LC 2. To see how well the patient's immune system responds to the MAGE-A3 ASCI treatment with or without the Poly IC:LC 3. To measure the rate of return of the patient's tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC 4. To measure the rate of return of the patient's tumor in two groups of patients: one group positive for the gene signature, and the other group not positive for the gene signature in their tumor after the MAGE-A3 ASCI treatment with or without the Poly IC:LC.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAGE-A3 ASCI injections without Poly IC:LC | Drug | — | UNRESOLVED |
| MAGE-A3 ASCI injections with Poly IC:LC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: recMAGE-A3 + AS15
- description
- ASCI injections without Poly IC:LC
- interventionNames
- Drug: MAGE-A3 ASCI injections without Poly IC:LC
- type
- ACTIVE_COMPARATOR
- label
- B: recMAGE-A3 + AS15 + Poly IC:LC
- description
- ASCI injections with Poly IC:LC
- interventionNames
- Drug: MAGE-A3 ASCI injections with Poly IC:LC
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events Related to Study Treatment
- timeFrame
- Beginning of Treatment to End of Follow Up - up to 5 years per participant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent for the study will be obtained prior to the performance of MAGE-A3 expression screening on resected tumor tissue or any other protocol-specific procedure. * Male or female patient with histologically proven and completely resected stage IV cutaneous or mucosal melanoma. In terms of the American Joint Committee on Cancer (AJCC) classification \[AJCC, 2009\], this means that patients with resected M1a-b-c (stage IV) disease may be enrolled. * The patient must have been surgically rendered free of disease no more than 12 weeks before the randomization. * Patient is equal to or greater than 18 years old at the time of signing the informed consent form. * The patient's tumor shows expression of the MAGE-A3 gene, as determined by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) analysis on paraffin imbedded tumor tissue (FFPE). In all patients in whom it can be obtained, a frozen portion of the resected tumor will be analyzed for gene profiling. * The patient has fully recovered from surgery. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at the time of randomization. * The patient must have adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria: Absolute neutrophil count (ANC) equal to or greater than 1.5 x 10\^9/L, Platelet count equal to or greater than 75 x 10\^9/L, Serum creatinine equal to or less than 1.5 times the Upper Limit of Normal (ULN), Total bilirubin equal to or less than 1.5 times the ULN, Transaminase (ALT - AST) equal to or less than 2.5 times the ULN * If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to randomization, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series. * Men must also agree to use an adequate method of contraception. * In the opinion of the investigator, the patient can and will comply with all the requirements of the protocol. Exclusion Criteria: * The patient has an ocular melanoma. * The patient has in-transit metastases. * The patient has been treated or is scheduled to be treated with an adjuvant anticancer therapy after the metastasectomy that qualifies the patient for inclusion in the present trial. * One prior systemic treatment with an immunomodulator (i.e., interferon, vaccine and/or anti-CTLA-4) after a previous surgery is permitted, provided that the last dose has been administered at least 45 days before randomization in the present trial. * Previous radiotherapy is permitted, provided that the treatment has been completed before the surgery that qualifies the patient for participation in the present trial. * The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of \< 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted. * Use of any investigational or non-registered product (drug or vaccine) other than the study treatment within 30 days preceding the randomization or planned use during the study period. * The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded. * The patient has a family history of congenital or hereditary immunodeficiency. * The patient is known to be positive for Human Immunodeficiency Virus (HIV) or has another confirmed or suspected immunosuppressive or immunodeficient condition. * History of allergic disease or reactions likely to be exacerbated by any component of the treatments. * The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures. * The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. * The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. * The patient has an uncontrolled bleeding disorder. * For female patients: the patient is pregnant or lactating.
References
Publications (0)
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