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

NCT03567889 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-12-17

No results posted yet for this study

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).

Conditions

  • Melanoma Stage IIIB
  • Melanoma Stage IIIC
  • Melanoma Stage IIID

Interventions

DRUG

Daromun

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

PROCEDURE

Surgery

Patients will receive surgery.

DRUG

Adjuvant therapy

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

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2027-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567889 on ClinicalTrials.gov