# 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

Source: https://onco.cc/trials/nct05732805/  
OnCo record `nct05732805` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing BCD-217 in melanoma, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT05732805, led by Biocad, and active but no longer recruiting on the registry. Official title: A Double-Blind Placebo-Controlled Comparative Randomised Clinical Study of the Efficacy and Safety 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. Planned enrolment is 270 participants (estimated). The study started in 2022-08-02 and primary completion is expected in 2024-06-20. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: OCTAVA
- Tags: ctgov-ingest
- Registry id: NCT05732805
- Phase: 3
- Setting: A Double-Blind Placebo-Controlled Comparative Randomized Clinical Study of the Efficacy and Safety 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
- Sponsor: Biocad
- Enrolled: 270

## Sources

- ClinicalTrials.gov NCT05732805: https://clinicaltrials.gov/study/NCT05732805

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [Melanoma](https://onco.cc/cancers/melanoma/)
- drugs: [BCD-100](https://onco.cc/drugs/bcd-100/), [BCD-217](https://onco.cc/drugs/bcd-217/)
- companies: [Biocad](https://onco.cc/companies/biocad/)
- key papers: [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](https://onco.cc/key-papers/paper-nct05732805-eur-j-cancer-2025/)

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