Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
← catalyst calendarNCT06284590 · readout ≤ 712 d
Sponsored by Philogen S.p.A. (industry) · PHIL.MI — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
162estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-12 | actual | When the study began enrolling |
| Primary completion | Jul 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-10-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Melanoma Stage III
- Melanoma Stage IV
Interventions
- Drug: L19IL2 — also filed as bifikafusp alfa
- Drug: L19TNF — also filed as onfekafusp alfa
- Drug: L19IL2/L19TNF — also filed as Daromun
- Drug: KEYTRUDA® — also filed as pembrolizumab
Primary outcome
what the primary-completion date above is the date OFConfirmed Objective Response Rate (ORR)
measured Evaluated over a period of up to 2 years after first intralesional treatment. TA visits will be performed at week 12, 18, 24, 36, 48, 64, 80 and 96 after first intralesional treatment or until confirmed progression or death, whichever occurs first
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