A Phase 3 clinical trial investigating Nivolumab (Opdivo) and BCD-263 as monotherapy for advanced melanoma of the skin completed its primary study on 2025-12-31. This significant milestone for study NCT06640530 was reported on ClinicalTrials.gov, indicating the conclusion of the main data collection period for assessing the efficacy and safety of the treatments.
Background
Nivolumab, marketed as Opdivo, is an established immunotherapy. This particular study, titled "Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin," focuses on its use in combination with or as a comparator to BCD-263. The trial specifically targets subjects diagnosed with advanced unresectable or metastatic melanoma of the skin, a serious form of skin cancer.
Trial design
The study, identified by its ClinicalTrials.gov identifier NCT06640530, is a Phase 3, active trial currently in the "Active, Not Recruiting" status. It was designed to enroll 392 participants. The study population includes individuals with advanced melanoma and melanoma of the skin. The interventions under investigation are BCD-263 and Opdivo. The overarching aim, as described in the trial summary, is to demonstrate comparable efficacy and a similar safety and immunogenicity profile between BCD-263 and Opdivo after repeated intravenous doses in the specified subject population.
Source
The information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov, a comprehensive public database of clinical studies. The event for study NCT06640530, titled "Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin," was reported with a primary completion date of 2025-12-31 on clinicaltrials.gov.