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Nidlegy (darleukin/fibromun)
i
Other names: L19-IL2 + L19-TNF, L19IL2-L19TNF, L19IL2/L19TNF
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News alerts, weekly reports and conference planners
Company:
Philogen, Sun Pharma
Drug class:
IL-2R agonist, TNF stimulant
Related drugs:
14d
Therapy of melanoma : Current standards and future perspectives (PubMed, Pathologie (Heidelb))
Multimodal treatment strategies have fundamentally improved the prognosis of melanoma. Therapy selection should be individualized based on molecular markers and disease stage. Future developments aim to integrate combination strategies, personalized immunotherapeutic approaches, and the overcoming of resistance mechanisms.
Review • Journal • IO biomarker
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LAG3 (Lymphocyte Activating 3)
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BRAF mutation • BRAF V600
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Nidlegy (darleukin/fibromun)
30d
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)
2ms
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
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
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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
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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
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
7ms
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)
8ms
L19IL2/L19TNF in Patients With Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Not yet recruiting, Philogen S.p.A.
New P2 trial
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
8ms
L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Not yet recruiting, Philogen S.p.A.
New P2 trial
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
8ms
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
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
1year
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)
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