NCT01983748|CompletedPhase 3DMC

Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

A NON-COMMERCIAL, 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

University Hospital Erlangen ClinicalTrials.gov

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1 other identifier

DERMA-ER-DC 08

Study Type

interventional

Target

200

Locations

1 country

Sites

Timeline

RegisteredNov 2013

StartedAug 2014

CompletionDec 2024

Brief Summary

Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA. 200 patients will be included. The Trial is an open multicenter Phase III Trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

200

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Aug 2014

Longer than P75 for phase_3

Geographic Reach

1 country

8 active sites

Status

completed

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

10.3 years study duration

First Submitted

Initial submission to the registry

September 17, 2013

Completed

2 months until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed

9 months until next milestone

Study Start

First participant enrolled

August 5, 2014

Completed

10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed

Last Updated

January 28, 2026

Status Verified

March 1, 2025

Enrollment Period

10.1 years

First QC Date

September 17, 2013

Last Update Submit

January 26, 2026

Conditions

Uveal Melanoma

Keywords

Uveal Melanoma, Monosomy 3

Outcome Measures

Primary Outcomes (1)

Prolongation of Overall survival
Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months, followed by telephone interviews.
Assessment every 3 months

Secondary Outcomes (1)

Prolongation of disease free survival
Assessment every 3 months

Other Outcomes (1)

Assessment for induction of immune responses
The induction of immune responses will be researched in selected patients (in a minimum of 15 survivors per trial arm) 2 years after randomization.

Study Arms (2)

A

EXPERIMENTAL

Biological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA

Biological: Autologous Dendritic Cells loaded with autologous Tumor RNA

B

NO INTERVENTION

Control, Standard of care, which is clinical control every 3 months

Interventions

Autologous Dendritic Cells loaded with autologous Tumor RNABIOLOGICAL

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 \[AJCC TNM grading 2009\]).
Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be determined by a validated qualitative analysis of loss of heterozygosity). Tumor material has to be stored appropriately in RNAlater solution for RNA preparation.
The patient has to be free of detectable tumor at the time point of study enrollment (adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest X-ray and evaluation of the tumor-marker S-100..
Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition.
Patients must be between 18 and 75 years old and must be able and willing to give informed consent.
Women of child-bearing age must have a negative pregnancy test, and must oblige to use effective contraception until at least 4 weeks after the last vaccination.
Patients must be willing to get hospitalized for at least 4 hours following vaccination(s), and to cooperate for the whole period of the trial.
Patients must have fully recovered from surgery.
Signed informed consent

You may not qualify if:

Any other major serious illness \[e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, cancer etc.\] or a contraindication to leukapheresis.
Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection.
Previous splenectomy or radiation therapy to the spleen.
Patients with organ allografts.
Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and paramedical substances. Patients may receive concomitant medications to control symptoms such as analgetics, antihypertensive medication, etc.
History of other active malignant neoplasm within the preceding 5 years (excluding non-melanoma skin cancer or carcinoma in situ of the cervix).
Organic brain syndrome or significant psychiatric abnormality which would impede informed consent and / or AND preclude participation in the full protocol and follow up.
Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the course of the trial to female patients in arm A or B, the patient has to be excluded.
Detection of metastases. If uveal melanoma metastases appear during the course of the trial, the patient has to be excluded.
Lack of compliance of the patient.

Contact the study team to confirm eligibility.