Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors.

ABSTRACT:

Background

Effector regulatory T cells expressing C-C chemokine receptor 4 (CCR4) suppress antitumor immune responses. We conducted a phase I clinical trial to evaluate the safety and efficacy of preoperative combination therapy with mogamulizumab (an anti-CCR4 antibody) and nivolumab (an anti-programmed death-1 antibody) in patients with solid tumors.

Methods

Patients with operable solid tumors were enrolled in a 3+3 design, with preoperative nivolumab (3.0 mg/kg) administered intravenously every 2 weeks three times and mogamulizumab at 0.1 mg/kg (cohort 1), 0.3 mg/kg (cohort 2), or 1.0 mg/kg (cohort 3) every week four times. The primary endpoints were safety and the effects of depleting Forkhead box P3⁺ (FoxP3⁺) T cells in the tumor.

Results

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SUBMITTER: Jinushi K 

PROVIDER: S-EPMC11966984 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature