Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

Anosys

Status and phase: Suspended; Phase 2

Conditions: Melanoma

Treatments: Biological: autologous dexosomes loaded with tumor-specific peptides

Study type: Interventional

Funder types: Industry

Identifiers

NCT00042497

AN2002-04

Details and patient eligibility

About

The objective is to determine the safety and efficacy of dexosome immunotherapy in patients with Stage IV malignant melanoma

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Patients with Stage IV metastatic melanoma with 0-1 prior treatments for metastatic disease.
• All patients must have distant skin, subcutaneous, or nodal metastases (M1a) or lung metastases (M1b), measurable disease, normal lactate dehydrogenase levels, and HLA type A1, A2, or B35.
• Patients must have adequate organ function and an estimated life expectancy of at least 3 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)