# Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized "Proof-of-principle" Phase II Study

> **NCT01973322** · PHASE2 · COMPLETED · sponsor: **Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS** · enrollment: 34 (actual)

## Conditions studied

- Malignant Melanoma of Skin Stage III
- Malignant Melanoma of Skin Stage IV

## Interventions

- **OTHER:** arm 1: DC Vaccine + RT
- **OTHER:** arm 2: DC Vaccine + IFN-alfa
- **OTHER:** arm 3: both arm 1 and 2 + RT
- **BIOLOGICAL:** arm 4: DC Vaccine

## Key facts

- **NCT ID:** NCT01973322
- **Lead sponsor:** Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-10-08
- **Primary completion:** 2023-09-30
- **Final completion:** 2024-06-20
- **Target enrollment:** 34 (ACTUAL)
- **Last updated:** 2025-01-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01973322

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01973322, "Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumor Lysate or Homogenate Combined With Immunomodulating Radiotherapy and/or Preleukapheresis IFN-alfa in Patients With Metastatic Melanoma: a Randomized "Proof-of-principle" Phase II Study". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT01973322. Licensed CC0.

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