Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients (LAG-3/IMP321)

This study has been terminated.
(Low enrollment rate)
Sponsor:
Collaborator:
Immutep S.A.
Information provided by (Responsible Party):
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01308294
First received: March 3, 2011
Last updated: October 14, 2014
Last verified: October 2014

March 3, 2011
October 14, 2014
June 2010
April 2014   (final data collection date for primary outcome measure)
  • Safety of vaccination will be assessed according to NCI CTC scale [ Time Frame: Change from baseline at week 31 ] [ Designated as safety issue: Yes ]
  • Immunological response (tumor antigen specific CD4 and CD8 T cell reactivity) will be measured by Tetramer analysis and ELISpot assays [ Time Frame: Change from baseline in CD8 T cells reactivity at week 31 ] [ Designated as safety issue: No ]
  • Safety of vaccination will be assessed according to NCI CTC scale [ Time Frame: After each vaccination and at the end of each vaccination cycle ] [ Designated as safety issue: Yes ]
  • Immunological response (tumor antigen specific CD4 and CD8 T cell reactivity) will be measured by Tetramer analysis and ELISpot assays [ Time Frame: At the end of each vaccination cycle ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01308294 on ClinicalTrials.gov Archive Site
Tumor response will be assessed by radiology in patients with measurable disease [ Time Frame: Change from baseline in tumor response at week 31 ] [ Designated as safety issue: No ]
Tumor response will be assessed by radiology in patients with measurable disease [ Time Frame: At the end of each vaccination cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
  • Biological: 2 vaccine injections in 1 limb
    All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other.
  • Biological: 2 vaccine injections in different limbs
    All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs.
  • Biological: 2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4
    All participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A peptide with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in different limbs.
  • Experimental: Group 1
    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)
    Intervention: Biological: 2 vaccine injections in 1 limb
  • Experimental: Group 2
    2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A, MAGE-A3-DP4 peptides + IMP321 + Montanide)
    Intervention: Biological: 2 vaccine injections in different limbs
  • Experimental: Group 3
    2 vaccine injections in different limbs (vaccine 1: NY-ESO-1, MAGE-3.A2, NA-17 peptides + IMP321 + Montanide) (vaccine 2: Melan-A peptide + IMP321 + Montanide)
    Intervention: Biological: 2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
April 2014
April 2014   (final data collection date for primary outcome measure)

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 ASAT, ALAT < 2.5 x upper limit of normal aPTT within the normal ranges ±25% 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01308294
P009-2010DR1082
No
Prof Olivier Michielin, M.D., Ph.D., Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Immutep S.A.
Principal Investigator: Olivier Michielin, MD PhD Oncology Department, Centre Hospitalier Universitaire Vaudois, Lausanne
Centre Hospitalier Universitaire Vaudois
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP