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NCT03567889 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
A Phase 3 study of Melanoma Stage IIIB and Melanoma Stage IIIC, sponsored by Philogen S.p.A..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT03567889: Recruiting Phase 3 study of Melanoma Stage IIIB and Melanoma Stage IIIC, sponsored by Philogen S.p.A..
NCT03567889 is a Phase 3 study of Melanoma Stage IIIB and Melanoma Stage IIIC that is actively recruiting participants, run by Philogen S.p.A.. The registered enrollment target is 186 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03567889, a Phase 3 study of Melanoma Stage IIIB and Melanoma Stage IIIC, is actively recruiting participants, sponsored by Philogen S.p.A..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Recurrence Free Survival (RFS) in a time-to-event analysis in the Daromun plus surgery and adjuvant therapy treatment group (Arm 1) versus the surgery and adjuvant therapy control group (Arm 2). Analysis will be performed for the "Intention To Treat" population.
Conditions Studied
Interventions
- PROCEDURE Surgery
- DRUG Daromun
- DRUG Adjuvant therapy
Study Locations (20)
Pennsylvania
- St. Luke's Cancer Center, Clinical Trial, 3rd floor, 1600 St. Luke's Blvd. - Easton
- Penn State Cancer Institute - Hershey
- Fox Chase Cancer Center 333 Cottman Avenue - Philadelphia
California
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health-Chao Family Comprehensive Cancer Center - Orange
New York
- Ambulatory Care Center at NYC Langarone Health - New York
- Memorial Sloan Kettering Cancer Center - Main Campus - Ney York
Arizona
- Mayo Clinic Hospital - Phoenix
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute, Emory university - Atlanta
Illinois
- Rush University Medical Center - Chicago
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2031-12 |
| Phase | Phase 3 |
What NCT03567889 shows while recruiting
NCT03567889 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 3 conditions, with Melanoma Stage IIIB appearing as the primary indexed condition, and to 3 interventions - of which Surgery is the first listed.
NCT03567889 names 20 study sites across 16 states, led by Pennsylvania, California, New York.
Frequently Asked Questions
What is clinical trial NCT03567889 about?
NCT03567889 is a clinical study titled "Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients". 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...
What is the current status of trial NCT03567889?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2018-09-20. Estimated completion is 2031-12.
What conditions does trial NCT03567889 study?
This clinical trial studies the following conditions: Melanoma Stage IIIB, Melanoma Stage IIIC, Melanoma Stage IIID.
What interventions are being tested in trial NCT03567889?
The interventions under investigation include: Surgery (PROCEDURE), Daromun (DRUG), Adjuvant therapy (DRUG).
Who is sponsoring clinical trial NCT03567889?
This trial is sponsored by Philogen S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03567889 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03567889's enrollment target sits among peer trials
186 1413th of 2000 higher than 584 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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