Trials Sponsors Conditions Drugs Pricing

Conditions

Adjuvant Drug Therapy Malignant Melanoma Vaccin Therapy

Keywords

Intradermal Autologous Dendritic Cell VaccineMalignant MelanomaAdjuvantvaccintherapyrandomized trialobservation

Outcome Measures

Primary Outcomes (1)

Relapse-free survival (RFS)
The time from the date of randomization to the date of the first relapse or the date of death from any cause or the date of the last restaging in non relapsed patients, assessed up to 36 months

Secondary Outcomes (2)

Overall survival (OS)
From the date of randomization until the date of death from any cause or the last date the patient was known to be alive, assessed up to 36 months
Immunologic efficacy will be measured by best delayed-type hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses
up to 36 months

Study Arms (2)

Arm A: Autologous Dendritic Cell vaccine

EXPERIMENTAL

Daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days starting from the second day after each vaccine dose. Vaccine doses will be given intradermally in two sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis.The first dose (WK1) will consist of freshly prepared vaccine, whereas for all the further doses cryopreserved aliquots will be utilized. The remaining 5 doses will be administered every 4 weeks to complete six months of therapy (six vaccines).

Biological: Autologous Dendritic Cell vaccine

Arm B: follow up

NO INTERVENTION

Arm B: Patients will undergo laboratory and clinical assessment, tumor re-staging, blood collection for immunological biomarkers every 12 weeks until relapse.

Interventions

Autologous Dendritic Cell vaccineBiological

The Dendritic Cells vaccine is given intradermally with 5 injections in sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis; as a rule, vaccine administrations should be performed by alternating injections sites. Two days after each vaccine administration, daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days.

Arm A: Autologous Dendritic Cell vaccine

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Signed Written Informed Consent: patients must be willing and able to give written informed consent, that have to be given before starting of screening procedure.
Availability of autologous tumor tissue fulfilling acceptance criteria prescribed by the "Product Specification File".

Sponsors & Collaborators

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Otherlead

Study Sites (2)

UO Immunoterapia e laboratorio TCS, IRST IRCCS

Meldola, FC, 47014, Italy

UO Oncologia Medica, IRCCS IRST

Meldola (FC), FC, 47014, Italy

Related Publications (1)

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.
PMID: 40251644DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Laura Ridolfi, MD
IRST IRCCS
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

March 24, 2016

Study Start

August 2015

Actual (reported)

Primary Completion

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm A: Autologous Dendritic Cell vaccine

Arm B: follow up

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Arm A: Autologous Dendritic Cell vaccine

Arm B: follow up

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations