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NCT06284590 · ClinicalTrials.gov registry record · Phase 2
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
A Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Philogen S.p.A..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
- 1
- Study location
NCT06284590: Recruiting Phase 2 study of Melanoma Stage IV and Melanoma Stage III, sponsored by Philogen S.p.A..
NCT06284590 is a Phase 2 study of Melanoma Stage IV and Melanoma Stage III that is actively recruiting participants, run by Philogen S.p.A.. The registered enrollment target is 162 participants, above the 93-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (74% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06284590, a Phase 2 study of Melanoma Stage IV and Melanoma Stage III, is actively recruiting participants, sponsored by Philogen S.p.A..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
- 1
- Study location
Study Summary
The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.
Primary Outcome
Objective Response Rate (ORR = CR + PR) in all three arms to demonstrate the efficacy of intralesional treatment with immunocytokines (L19IL2, or L19TNF, or L19IL2/L19TNF), in combination with the systemic anti-PD1 pembrolizumab, to induce objective responses in advanced melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors. The primary analysis will be performed in the Intention-to-Treat population (ITT). Assessed during Tumor Assessment (TA) visits.
Conditions Studied
Interventions
- DRUG L19TNF
- DRUG L19IL2
- DRUG L19IL2/L19TNF
- DRUG KEYTRUDA®
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2024-07-12 |
| Est. Completion | 2028-07 |
| Phase | Phase 2 |
What NCT06284590 shows while recruiting
NCT06284590 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 93-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (74% higher).
The record links to 2 conditions, with Melanoma Stage IV appearing as the primary indexed condition, and to 4 interventions - of which L19TNF is the first listed.
NCT06284590 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06284590 about?
NCT06284590 is a clinical study titled "Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients". The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.
What is the current status of trial NCT06284590?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2024-07-12. Estimated completion is 2028-07.
What conditions does trial NCT06284590 study?
This clinical trial studies the following conditions: Melanoma Stage IV, Melanoma Stage III.
What interventions are being tested in trial NCT06284590?
The interventions under investigation include: L19TNF (DRUG), L19IL2 (DRUG), L19IL2/L19TNF (DRUG), KEYTRUDA® (DRUG).
Who is sponsoring clinical trial NCT06284590?
This trial is sponsored by Philogen S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06284590 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma Stage IV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06284590's enrollment target sits among peer trials
162 4th of 17 higher than 14 of 17 other Melanoma Stage IV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma Stage IV 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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