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

NCT02718391 | Terminated Phase 2

• 2 other identifiers: IRST172.042014-005123-27
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Melanoma; Adjuvant Drug Therapy; Vaccin Therapy

Keywords

Intradermal Autologous Dendritic Cell Vaccine; Malignant Melanoma; Adjuvant; vaccin; therapy; randomized trial; observation

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 vaccine BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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".
• Patients must have histologically or cytologically confirmed melanoma (all type of melanomas);
• Patients must be disease free after surgical removal of a metastatic lesions (stage IV or metachronous stage III)
• Eastern Cooperative Oncology Group performance status 0-1
• Negative screening tests for HIV, Hepatitis B virus, Hepatitis C virus and syphilis not older than 30 days before performing any of the Good Manufacturing Practice-regulated activities required (leukapheresis, collection of tumor biopsies to be used for tumor lysate/homogenate preparation);
• Men and women aged ≥ 18 years.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up 8 weeks after the study, in order to minimize the risk of pregnancy;
• Patients must have normal organ and marrow function according to clinical practice.

You may not qualify if:

• Patients who have positive tests to Hepatitis B virus, Hepatitis C virus HIV, or syphilis (specific blood testing must be performed within 30 days before any Good Manufacturing Practice-regulated activity (leukapheresis and collection of tumor biopsies to be used for tumor lysate preparation).
• Patients who have had prior lines of systemic chemotherapy, immunotherapy or biological therapy for metastatic melanoma.
• Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements (on physician's judgment).
• Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
• Any contraindication to undergo leukapheresis as evaluated by transfusionist (e.g. severe anemia, thrombocytopenia, oral anticoagulant therapy) or to undergo surgery

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (2)

UO Immunoterapia e laboratorio TCS, IRST IRCCS

Meldola, FC, 47014, Italy

Location

UO Oncologia Medica, IRCCS IRST

Meldola (FC), FC, 47014, Italy

Location

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: 40251644 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Ridolfi, MD

  IRST IRCCS

  PRINCIPAL INVESTIGATOR

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 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 22, 2020

Record last verified: 2019-04

Locations

IT (2)