Pharmacokinetic, Safety, and Immunogenicity Comparison of Bmab1700 Versus Nivolumab as Adjuvant Monotherapy in Stage IIB–C, III, and IV Melanoma

Primary objective: to compare the pharmacokinetics, safety, and immunogenicity of Bmab1700 versus Opdivo® when given as adjuvant monotherapy in patients with stage IIB/C, stage III, or stage IV melanoma; this assessment will determine relative drug exposure, adverse event incidence, and anti‑drug antibody formation, which are essential for informing therapeutic selection in the adjuvant setting.

Seventy‑seven individuals were enrolled, comprising both female and male patients diagnosed with Stage IIB/C, Stage III, or Stage IV Melanoma. The cohort included subjects classified under age‑range codes 3 and 4, reflecting the trial’s predefined adult age categories. All participants were selected on the basis of having the specified stages of melanoma and were otherwise required to be in generally stable health to permit study procedures. The trial population consisted exclusively of patients rather than healthy volunteers, and no additional lifestyle restrictions such as specific diet or activity regimens were stipulated in the provided information.

The study is a randomized, double-blind, controlled Phase 1 trial evaluating the pharmacokinetics, safety, and immunogenicity of Bmab1700 versus Opdivo® as adjuvant monotherapy in patients with melanoma (Stage IIB/C, III, or IV). Recruitment is planned to commence on 16 September 2026 and conclude by 1 June 2028. Eligible participants undergo an initial screening visit to confirm inclusion criteria, followed by a baseline visit on Day 1 when the assigned study drug is administered. Subsequent follow‑up visits occur at predefined intervals (e.g., Weeks 2, 4, 8, 12, and then monthly) to collect blood samples for pharmacokinetic and immunogenicity assessments, monitor safety parameters, and record adverse events. The end‑of‑study visit, scheduled approximately 12 months after the first dose, completes the observation period. Participant involvement therefore spans roughly one year from the first dose to the final assessment. Early termination may occur if a participant experiences a serious adverse reaction, fails to adhere to the protocol, withdraws consent, or meets pre‑specified stopping criteria defined by the safety monitoring committee.

No treatment details were provided in the source information.

Efficacy assessments will be performed in accordance with the study protocol.