Clinical trial · Interventional
Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients
Vaccination of Melanoma Patients (Stage II-IV) With ImmuFact IMP321, Tumor Antigenic Peptides and Montanide
NCT01308294CI-TRIAL-00045482LAG-3/IMP321terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment rate
Summary
Brief summary (as posted)
The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety and tolerability of this vaccination. Tumor responses following this vaccination will also be documented.
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 |
|---|---|---|---|
| 2 vaccine injections in 1 limb | Biological | — | UNRESOLVED |
| 2 vaccine injections in distinct limbs | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 2 vaccine injections in 1 limb
- description
- 9 patients initially planned: patients received peptides with IMP321/LAG-3Ig and Montanide in 2 injections sites at 5 cm distance from each other 2 vaccine injections in same limb (vaccine 1 : NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2 : Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)
- interventionNames
- Biological: 2 vaccine injections in 1 limb
- type
- EXPERIMENTAL
- label
- 2 vaccine injections in distinct limbs
- description
- Groupe2: 2 vaccine injections in different limb should include 9 patients that were initially planned: patients received the same vaccine in 2 syringes injected each in a distinct limb (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)
- interventionNames
- Biological: 2 vaccine injections in distinct limbs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed stage II, III or IV melanoma patients. * Tumor expression of Melan-A. * Human leukocyte antigen-A2 (HLA-A2) positive. * Expected survival of at list 3 months. * Karnofsky scale performance status of 70 % or more. * Age ≥ 18 years. * Able to give a written informed consent. * The following laboratory results: Hemoglobin ≥ 100g/L, Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 100 x 109/L, Serum creatinine ≤ 2 mg/dL (0.18mmol/L), Serum bilirubin ≤ 2mg/dL (0.034mmol/L), Granulocyte count \> 2.5x109/L, Aspartate Amino Transférase (ASAT), Alanine Amino Transferase (ALAT) \< 2.5 x upper limit of normal, Activated Partial Thromboplastin Time (aPTT) within the normal ranges ±25%, Thromplastin (TP) ≥ 80% Exclusion Criteria: * Clinically significant heart disease. * Serious illness, eg. serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders. * History of immunodeficiency disease or autoimmune disease. * Metastatic disease to the central nervous system, unless treated and stable. * Known HIV positivity. * Known seropositivity for hepatitis B surface antigen. * Concomitant treatment with steroids, antihistamine drugs. Topical or inhalation steroids are permitted. * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. * Pregnancy or lactation. * Women of childbearing potential not using a medically acceptable means of contraception. * Psychiatric or addictive disorders that may compromise the ability to give informed consent. * Lack of availability of the patient for immunological and clinical follow-up assessment. * Coagulation or bleeding disorders. * Kidney dysfunction with creatinine \> 2 X the upper limit of the normal value. * Reported strong (allergic) reactions to previous vaccination.
References
Publications (4)
- BACKGROUNDSierro S, Romero P, Speiser DE. The CD4-like molecule LAG-3, biology and therapeutic applications. Expert Opin Ther Targets. 2011 Jan;15(1):91-101. doi: 10.1517/14712598.2011.540563. PMID 21142803
- BACKGROUNDBrignone C, Escudier B, Grygar C, Marcu M, Triebel F. A phase I pharmacokinetic and biological correlative study of IMP321, a novel MHC class II agonist, in patients with advanced renal cell carcinoma. Clin Cancer Res. 2009 Oct 1;15(19):6225-31. doi: 10.1158/1078-0432.CCR-09-0068. Epub 2009 Sep 15. PMID 19755389
- BACKGROUNDSpeiser DE, Romero P. Molecularly defined vaccines for cancer immunotherapy, and protective T cell immunity. Semin Immunol. 2010 Jun;22(3):144-54. doi: 10.1016/j.smim.2010.03.004. Epub 2010 Apr 21. PMID 20413326
- RESULTLegat A, Maby-El Hajjami H, Baumgaertner P, Cagnon L, Abed Maillard S, Geldhof C, Iancu EM, Lebon L, Guillaume P, Dojcinovic D, Michielin O, Romano E, Berthod G, Rimoldi D, Triebel F, Luescher I, Rufer N, Speiser DE. Vaccination with LAG-3Ig (IMP321) and Peptides Induces Specific CD4 and CD8 T-Cell Responses in Metastatic Melanoma Patients--Report of a Phase I/IIa Clinical Trial. Clin Cancer Res. 2016 Mar 15;22(6):1330-40. doi: 10.1158/1078-0432.CCR-15-1212. Epub 2015 Oct 23. PMID 26500235