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Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

A Phase II, Multicenter, Open-Labeled Study of Immunotherapy With Autologous Dexosomes for Patients With Stage IV Melanoma

Status
Suspended
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00042497
Enrollment
60
Registered
2002-08-01
Start date
2002-07-31
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

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

Interventions

BIOLOGICALautologous dexosomes loaded with tumor-specific peptides

Sponsors

Anosys
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026