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
Published report from the OCTAVA trial registered as NCT05732805, in European Journal of Cancer (2025), chosen as the most cited paper whose own text cites the registry id.
Overview
Background: OCTAVA (NCT05732805) was an international, multi-center, randomized, double-blind, phase III study evaluating the fixed-dose combination of nurulimab (anti-CTLA-4) and prolgolimab (anti-PD-1) (BCD-217, Nuru+Prolgo) followed by prolgolimab maintenance versus prolgolimab monotherapy as first-line treatment for unresectable or metastatic melanoma (un/mM). We present the primary analysis results.
Methods: Treatment-naïve patients with un/mM were randomized 1:1 to Nuru+Prolgo (n = 135) or prolgolimab (n = 136) for 4 cycles, followed by prolgolimab maintenance for up to two years. The primary endpoint was progression-free survival (PFS) by iRECIST.
Results: With a median follow-up of 15.8 months, median PFS was significantly longer with nurulimab+prolgolimab [15.4 months (95 % CI, 10.3-ND)] compared to prolgolimab monotherapy [10.8 months (4.7-ND)] (HR 0.68; 95 % CI, 0.482-0.957; iRECIST). RECIST 1.1 analysis confirmed this benefit (mPFS 9.9 vs 2.8 months). ORR and DCR were also higher in the combination arm. Grade 3-4 treatment-related AE: 16.3 % (combination) vs 14.0 % (monotherapy). Immune-related AEs (irAE): 52.6 % vs 32.4 % (p = 0.0007); Gr. ≥ 3 irAE: 13.3 % vs 5.9 % (p = 0.04). Discontinuations due to AE: 9.6 % vs 4.4 %.
Conclusions: The Nuru+Prolgo fixed-dose combination demonstrated significantly superior efficacy versus aPD-1 monotherapy in first-line un/mM, with a manageable safety profile.
Indexed on Europe PMC as PubMed record 40795521 (DOI 10.1016/j.ejca.2025.115674). Its abstract cites the registry id NCT05732805, which is how it was matched to this trial; no figure has been checked by an editor.
This is the paper Europe PMC returns for registry id NCT05732805 with the most citations, so it is the natural first reading for anyone following the OCTAVA trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.