RecruitingPhase 3NCT03567889

Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients

An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C/D Melanoma Patients

Sponsor

Philogen S.p.A.

Enrollment

186 participants

Start Date

Sep 20, 2018

Study Type

INTERVENTIONAL

Conditions

Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IIID

Summary

The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C/D melanoma patients with respect to the standard of care (surgery and adjuvant therapy).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination drug treatment called Daromun — injected directly into melanoma tumors — before surgery in patients with advanced melanoma that has spread to nearby lymph nodes or skin but can still be completely removed with surgery. **You may be eligible if...** - You have been diagnosed with stage IIIB, IIIC, or IIID melanoma (advanced but still removable cancer) - All your melanoma spots can be surgically removed - You have at least one tumor that can be injected (at least 10 mm in size, or multiple smaller tumors adding up to that size) - You have had prior treatment for the original melanoma **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage IV) - Your tumors cannot be fully removed with surgery - You do not have a tumor that is large enough or accessible for direct injection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaromun

Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks.

PROCEDURESurgery

Patients will receive surgery.

DRUGAdjuvant therapy

Patients will receive adjuvant therapy at the investigator's discretion following the surgery.

Locations(37)

Mayo Clinic Hospital

Phoenix, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

UC Irvine Health-Chao Family Comprehensive Cancer Center

Orange, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory university

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Mayo Clinic

Rochester, Minnesota, United States

Rutgers Cancer Institute, 195 Little Albany Street

New Brunswick, New Jersey, United States

Ambulatory Care Center at NYC Langarone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center - Main Campus

Ney York, New York, United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd.

Easton, Pennsylvania, United States

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Fox Chase Cancer Center 333 Cottman Avenue

Philadelphia, Pennsylvania, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute, University of Utah 2000 Circle of Hope

Salt Lake City, UT, Utah, United States

VCU - McGlothlin Medical Education Center

Richmond, Virginia, United States

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Barcelona, Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Barcelona, Spain

El Hospital Universitario De Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, Canarie, Spain

Fundacion Onkologikoa Fundazioa

Donostia / San Sebastian, Gipuzkoa, Spain

MD Anderson Cancer Center

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Regional de Málaga

Málaga, Malaga, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Hospital Universitario Virgen De La Macarena

Seville, Sevilla, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Universitätsspital Basel

Basel, Basel, Switzerland

Istituto Oncologico della Svizzera Italiana

Bellinzona, Bellinzona, Switzerland

Insel Gruppe AG

Bern, Canton of Bern, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Canton of Geneva, Switzerland

Kantonsspital St.Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Universitätsspital Zürich (USZ)

Zurich, Canton of Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT03567889