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Vaccination of Melanoma Patients (Stage II-IV) With ImmuFact IMP321, Tumor Antigenic Peptides and Montanide


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

Vaccination of Melanoma Patients (Stage II-IV) With ImmuFact IMP321, Tumor Antigenic Peptides and Montanide


Inclusion Criteria:



- Histologically confirmed stage II, III or IV melanoma patients

- Tumor expression of Melan-A

- Human leukocyte antigen-A2 (HLA-A2) positive

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

- Coagulation or bleeding disorders

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of vaccination will be assessed according to NCI CTC scale

Outcome Time Frame:

Change from baseline at week 31

Safety Issue:

Yes

Principal Investigator

Olivier Michielin, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Department, Centre Hospitalier Universitaire Vaudois, Lausanne

Authority:

Switzerland: Swissmedic

Study ID:

P009-2010DR1082

NCT ID:

NCT01308294

Start Date:

June 2010

Completion Date:

December 2014

Related Keywords:

  • Melanoma
  • Melanoma
  • Stage II-IV
  • Immunotherapy
  • Vaccination
  • HLA class I and II tumor-specific peptides
  • IMP321
  • Montanide ISA-51 VG
  • Melanoma

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