Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients.

Summary

This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.

Timeline

Start

2015-08

Primary completion

2019-11

Completion

2019-11

Outcome

Outcome not reported

Stopped: “The randomization to the observational arm of the trial was no longer ethical”

Publications

• Bulgarelli J, Piccinini C, Scarpi E, Gentili G, Renzi L, Carloni S, Limarzi F, Pancisi E, Granato AM, Petrini M, De Rosa F, Guidoboni M, Fanelli D, Tumedei MM, Tazzari M, Baravelli S, Bronico I, Cortesi P, Pignatta S, Capelli L, Ancarani V, Foschi G, Turci L, Tauceri F, Framarini M, Ridolfi L. Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial. J Transl Med. 2025 Apr 18;23(1):455. doi: 10.1186/s12967-025-06403-8.

Drugs

Indications