Cancer vaccine containing dendritic cells for uveal melanoma patients

A multicenter, randomized, two-armed, open-label Phase III study to evaluate the adjuvant vaccination with tumor RNA-loaded autologous Dendritic Cells versus observation of patients with resected monosomy 3 uveal melanoma - Uveal melanoma / Dendritic Cells + autologous tumor RNA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007847-28-DE

Enrollment

200

Registered

2010-11-12

Start date

2011-09-16

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Patients with resected uveal melanoma showing monosomy 3, free of metastases MedDRA version: 20.0 Level: HLT Classification code 10030052 Term: Ocular melanomas System Organ Class: 100000004853

Interventions

Product Name: Autologous Dendritic Cells + autologous tumor-RNA (uveal melanoma) Product Code: DCaT-RNA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Autologous dendritic cells loade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Resected uveal melanoma displaying monosomy 3, no evidence for metastases, WHO performance status of 0, 1 or 2, age over 18 years, negative pregnancy test, signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: Evidence for metastases, seriously impaired haematological, hepatic or renal function, major serious illness, evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection, autoimmune diseases, splenectomy or radiation therapy of the spleen, organ allografts, simultaneous chemo- or radiation therapy, simultaneous immunotherapy, pregnancy, lactation, psychiatric disorders, organic brain syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: To prolong disease free survival by prevention or delay of metastases;Secondary Objective: To prolong overall survival, to induce anti tumor immune responses ;Primary end point(s): Overall survival Assess how long disease free survival of patients lasts by performing imaging based evaluations;Timepoint(s) of evaluation of this end point: Every 3 months or earlier in case of symptoms	—

Measure

Time frame

Main Objective: To prolong disease free survival by prevention or delay of metastases;Secondary Objective: To prolong overall survival, to induce anti tumor immune responses ;Primary end point(s): Overall survival Assess how long disease free survival of patients lasts by performing imaging based evaluations;Timepoint(s) of evaluation of this end point: Every 3 months or earlier in case of symptoms

—

Secondary

Measure	Time frame
Secondary end point(s): Immune responses;Timepoint(s) of evaluation of this end point: End of study	—

Countries

Germany

Contacts

Public ContactHautklinik

Universitätsklinikum Erlangen

experimentelle-immuntherapie@uk-erlangen.de+4991318533724

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026