{"entity":{"id":"nct05732805","kind":"trial","name":"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","aka":["OCTAVA"],"tldr":"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.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05732805","url":"https://clinicaltrials.gov/study/NCT05732805"}],"tags":["ctgov-ingest"],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":[],"targets":[],"drugs":["bcd-217","bcd-100"],"companies":["biocad"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05732805-eur-j-cancer-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2022-08-02","startedType":"actual","enrolled":270,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05732805/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"drug":[{"id":"bcd-100","kind":"drug","name":"BCD-100","route":"/drugs/bcd-100/"},{"id":"bcd-217","kind":"drug","name":"BCD-217","route":"/drugs/bcd-217/"}],"company":[{"id":"biocad","kind":"company","name":"Biocad","route":"/companies/biocad/"}],"paper":[{"id":"paper-nct05732805-eur-j-cancer-2025","kind":"paper","name":"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","route":"/key-papers/paper-nct05732805-eur-j-cancer-2025/"}]}}