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Nidlegy (darleukin/fibromun)
i
Other names: L19-IL2 + L19-TNF, L19IL2-L19TNF, L19IL2/L19TNF
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Company:
Philogen, Sun Pharma
Drug class:
IL-2R agonist, TNF stimulant
Related drugs:
8d
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
P2, N=180, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Jun 2026
Enrollment open • Trial initiation date
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
1m
L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting
Enrollment open • Trial initiation date
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Nidlegy (darleukin/fibromun)
4ms
PH-ICKPD1-02/21: A phase 2 study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 Pembrolizumab, in stage III/IV unresectable melanoma patients with resistance to anti-PD1 checkpoint inhibitors (INTACT / MeRCI) (2024-519326-20-00)
P1/2, N=65, Not yet recruiting, Philogen S.p.A.
New P1/2 trial • Checkpoint inhibition
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BRAF (B-raf proto-oncogene)
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BRAF mutation
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Keytruda (pembrolizumab) • Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
4ms
L19IL2/L19TNF in patients with cutaneous squamous cell carcinoma (2025-523231-19-00)
P1/2, N=54, Not yet recruiting, Philogen S.p.A.
New P1/2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
4ms
L19IL2/TNF in patients with basal cell carcinoma (2025-523230-77-00)
P1/2, N=53, Not yet recruiting, Philogen S.p.A.
New P1/2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
4ms
PHL19IL2TNFCOMB04/24: L19IL2 or L19TNF or L19IL2/TNF in patients with basal cell carcinoma (BCC) (2025-523229-16-00)
P1/2, N=85, Not yet recruiting, Philogen S.p.A.
New P1/2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
6ms
Neo-DREAM: Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients (clinicaltrials.gov)
P3, N=186, Recruiting, Philogen S.p.A. | Trial completion date: Jun 2026 --> Dec 2031 | Trial primary completion date: Jun 2024 --> Dec 2027
Trial completion date • Trial primary completion date
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Nidlegy (darleukin/fibromun)
7ms
L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Not yet recruiting, Philogen S.p.A.
New P2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
7ms
L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Not yet recruiting, Philogen S.p.A.
New P2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
7ms
L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC) (clinicaltrials.gov)
P2, N=180, Not yet recruiting, Philogen S.p.A.
New P2 trial
|
Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
11ms
Efficay and Safety of DAROMUN on Patient Treated by Intralesionnal Injection: DAROMEL (clinicaltrials.gov)
P=N/A, N=70, Not yet recruiting, Centre Hospitalier Universitaire de Nice
New trial
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Nidlegy (darleukin/fibromun)
1year
New therapeutic approaches in the neoadjuvant/adjuvant treatment of melanoma (PubMed, Dermatologie (Heidelb))
The mRNA-based treatment combined with checkpoint inhibitors have the potential to induce long-term immune responses. The efficacy of LAG-3 inhibitors in the adjuvant setting is currently under evaluation in clinical studies. The immunocytokine treatment with daromun shows promising results in the neoadjuvant setting by stimulating both local and systemic immune responses. Future studies should focus on identifying optimal combinations of treatment to improve the long-term prognosis of patients.
Review • Journal
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LAG3 (Lymphocyte Activating 3)
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Keytruda (pembrolizumab) • Kimmtrak (tebentafusp-tebn) • Nidlegy (darleukin/fibromun)
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