Feasibility Study of Targeted Nivolumab Immunotherapy Before Surgery in Women with Early-Stage Cervical Cancer

What this Trial Is About

Researchers are evaluating the feasibility, safety, and efficacy of targeted immune checkpoint inhibition using different doses of nivolumab in female patients with newly diagnosed early-stage cervical cancer FIGO stage less than IB3. This single-arm, single-center phase 1 study focuses on neoadjuvant treatment, meaning nivolumab is given before standard surgery to assess its impact and determine the best dose. Participants will receive two subcutaneous injections of nivolumab at doses of 5, 10, 15, or 30 mg, administered every three weeks in the inner-upper thigh to target tumor-draining lymph nodes. This treatment occurs between diagnosis and standard-of-care surgery, after which adjuvant therapy follows. The study lasts approximately 11 weeks, including late follow-up visits at 3 and 6 months after treatment. During the study, participants will undergo assessments including MRI scans before starting nivolumab and three weeks after the last dose, as well as tissue collection during surgery to evaluate pathologic response. Researchers will monitor safety, toxicity, feasibility of treatment without surgery delays, and radiologic responses. The main outcome is the proportion of participants completing planned surgery without treatment-related delays. The total participant involvement spans about 11 weeks with additional follow-up visits months later.

Neoadjuvant Lymph Node Targeted Immunotherapy in Cervical Cancer: a Feasibility Study (NEOLYNC)