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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Nurdati (prolgolimab/nurulimab)
i
Other names: BCD-217, Anti-CTLA-4/Anti-PD-1 FDC, BCD 217, BCD217
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News alerts, weekly reports and conference planners
Company:
Biocad
Drug class:
PD1 inhibitor, CTLA4 inhibitor
Related drugs:
4ms
Improved clinical outcomes with low-dose anti-CTLA-4 (Nurulimab) plus anti-PD-1 (Prolgolimab) vs. anti-PD-1 monotherapy in advanced cutaneous melanoma: Results from the phase III OCTAVA trial. (PubMed, Eur J Cancer)
The Nuru+Prolgo fixed-dose combination demonstrated significantly superior efficacy versus aPD-1 monotherapy in first-line un/mM, with a manageable safety profile.
Clinical • Clinical data • P3 data • Journal
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IL17RA (Interleukin 17 Receptor A)
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Forteca (prolgolimab) • Nurdati (prolgolimab/nurulimab)
5ms
NEO-MIMAJOR: A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma (clinicaltrials.gov)
P3, N=411, Active, not recruiting, Biocad | Recruiting --> Active, not recruiting
Enrollment closed
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Keytruda (pembrolizumab) • Nurdati (prolgolimab/nurulimab)
9ms
OCTAVA: A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (clinicaltrials.gov)
P3, N=270, Active, not recruiting, Biocad | Recruiting --> Active, not recruiting | Trial completion date: Apr 2025 --> Jul 2025
Enrollment closed • Trial completion date
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Nurdati (prolgolimab/nurulimab)
almost3years
NEO-MIMAJOR: A Study of Neoadjuvant Therapy With BCD-217 (Nurulimab + Prolgolimab) in Patients With Resectable Stage III Skin Melanoma (clinicaltrials.gov)
P3, N=410, Recruiting, Biocad
New P3 trial
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Keytruda (pembrolizumab) • Nurdati (prolgolimab/nurulimab)
almost3years
OCTAVA: A Clinical Study of BCD-217 (Nurulimab + Prolgolimab) Followed by Anti-PD-1 Compared to Anti-PD-1 Monotherapy as First-Line Treatment in Subjects With Unresectable/Metastatic Melanoma (clinicaltrials.gov)
P3, N=270, Recruiting, Biocad
New P3 trial • Metastases
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Nurdati (prolgolimab/nurulimab)
almost3years
OBERTON: Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
P2, N=117, Active, not recruiting, Biocad | Unknown status --> Active, not recruiting | Trial completion date: Nov 2021 --> Dec 2023 | Trial primary completion date: Aug 2021 --> Jul 2023
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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PD-L1 expression • BRAF V600
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Nurdati (prolgolimab/nurulimab)
over5years
OBERTON: Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
P2, N=112, Recruiting, Biocad | Not yet recruiting --> Recruiting | Trial completion date: Sep 2022 --> Nov 2021
Clinical • Enrollment open • Trial completion date
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
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PD-L1 expression • BRAF V600
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Forteca (prolgolimab) • Nurdati (prolgolimab/nurulimab)
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