NCT00365937

Brief Summary

Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2013

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

7.4 years

First QC Date

August 17, 2006

Last Update Submit

March 4, 2019

Conditions

Melanoma

Keywords

immunotherapyadjuvantsIMP321Montanide ISA51 VGtumor-specific peptides

Outcome Measures

Primary Outcomes (1)

  • Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants

Secondary Outcomes (1)

  • Secondary: Disease-free survival.

Study Arms (4)

Group A

EXPERIMENTAL

The eight HLA-A2 peptides

Biological: Immunological peptides and immunological adjuvantsBiological: HLA-A2 peptides

Group B

EXPERIMENTAL

The eight HLA-A2 peptides + immunological adjuvant Montanide ISA51

Biological: Immunological peptides and immunological adjuvantsBiological: HLA-A2 peptidesBiological: Montanide ISA51

Group C

EXPERIMENTAL

the eight peptides HLA-A2 + IMP321

Biological: Immunological peptides and immunological adjuvantsBiological: HLA-A2 peptidesBiological: IMP321

Group D

EXPERIMENTAL

The eight HLA-A2 peptides + the 2 immunological adjuvants (Montanides ISA 51 and IMP321)

Biological: Immunological peptides and immunological adjuvantsBiological: HLA-A2 peptidesBiological: Montanide ISA51Biological: IMP321

Interventions

Immunological peptides and immunological adjuvantsBIOLOGICAL
Group AGroup BGroup CGroup D
HLA-A2 peptidesBIOLOGICAL

Tyrosinase.A2: lyophilized powder, 326 mcg, 5 injections every 3 weeks MAGE-C2.A2: lyophilized powder, 320 mcg, 5 injections every 3 weeks NY-ESO-1b.A2: lyophilized powder, 290 mcg, 5 injections every 3 weeks MAGE-4.A2: lyophilized powder, 299 mcg, 5 injections every 3 weeks MAGE-3.A2: lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-1.A2: lyophilized powder, 298 mcg, 5 injections every 3 weeks NA17.A2 (GnTV): lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-10.A2: lyophilized powder, 309 mcg, 5 injections every 3 weeks

Group AGroup BGroup CGroup D
Montanide ISA51BIOLOGICAL

Oil emulsion (W/O: droplet test S57 IN 001), conductivity less than 10mcs.cm-1, viscosity: 1500 mPas (brookfield DVI - spindle 2- Speed 30). For human applications. Injected 5 times every 3 weeks.

Group BGroup D
IMP321BIOLOGICAL

Official name of the LAG-3 molecule is CD223. Chemical structure: hLAG-3Ig is a soluble human recombinant LAG-3 protein comprising the extra-cellular Ig-like domains. The IMP321 drug product is composed of a soluble recombinant protein at a 1.18 mg/ml concentration, in PBS (Na2HPO4 2H2O 8.1mM, KH2PO4 1.47mM, NaCl 137mM, KCl 2.68mM, PH 7.2). Batch number: S017/LC1/041011.IMP321 will be provided in 250mcl aliquots in brosilicate siliconized vials.

Group CGroup D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven cutaneous melanoma.
  • Patient's melanoma must be in one of the following AJCC stages :
  • only primary tumor : T3b-T4, N0, M0. regional lymph node metastasis and/or in-transit metastasis, no distant metastasis (any T, N1-N3, M0) that has been removed.
  • Any distant metastasis that has been removed (M1) HLA-A2 positive. Patients with previous regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase or NY-ESO-1. However, expression of these genes by the tumor is not required to enter the study.
  • Absence of detectable melanoma lesions. WHO/ECOG performance status of 1 or less (Karnofsky scale ≥ 70%).
  • The following laboratory results:
  • Hemoglobin ≥ 10 g/dl; Neutrophils ≥ 1,500/µl; Lymphocytes ≥ 700/µl; Platelets ≥ 100,000/µl; Serum creatinin ≤ 2.0 mg/dl; Serum bilirubin ≤ 2.0 mg/dl; LDH within normal institutional limits.
  • Age \> 18 years. Able to give written informed consent.

You may not qualify if:

  • Clinically significant heart disease (NYHA Class III or IV). Other serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, a second active malignancy, except basal cell carcinoma or in situ carcinoma of the uterine cervix.
  • Active immunodeficiency disease or autoimmune disease. Positive serology for HIV (human immunodeficiency virus) or HCV (hepatitis C virus). Serum hepatitis B antigen (HBsAg) must be negative.
  • More than one line of previous chemotherapy, or immunotherapy for the melanoma. Previous vaccination with one of the antigen present in the vaccine. Treatment with steroids or major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalational 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Melanoma

Interventions

Adjuvants, Immunologicmontanide ISA 51soluble LAG-3 protein, human

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Jean-François Baurain, M.D, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

August 1, 2006

Primary Completion

December 13, 2013

Study Completion

December 13, 2013

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

BE(1)