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
  Purpose

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.


Condition Intervention Phase
Melanoma
Biological: 2 vaccine injections in 1 limb
Biological: 2 vaccine injections in different limbs
Biological: 2 vaccine injections in different limbs, the vaccine does not contain the MHC class II peptide MAGE-A3-DP4
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vaccination of Melanoma Patients (Stage II-IV) With ImmuFact IMP321, Tumor Antigenic Peptides and Montanide

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: June 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
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)
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.
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308294

Locations
Switzerland
Oncology Department, CHUV
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Immutep S.A.
Investigators
Principal Investigator: Olivier Michielin, MD PhD Oncology Department, Centre Hospitalier Universitaire Vaudois, Lausanne
  More Information

Publications:
Responsible Party: Prof Olivier Michielin, M.D., Ph.D., Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01308294     History of Changes
Other Study ID Numbers: P009-2010DR1082
Study First Received: March 3, 2011
Last Updated: October 14, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Melanoma
Stage II-IV
Immunotherapy
Vaccination
HLA class I and II tumor-specific peptides
IMP321
Montanide ISA-51 VG

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 16, 2014