Phase II Study of Pre-Surgery Treatment with Iparomlimab and Tuvonralimab Plus Chemotherapy for Locally Advanced Cervical Cancer

What this Trial Is About

Locally advanced cervical cancer LACC is a serious health issue with limited treatment options. Researchers are evaluating the use of neoadjuvant therapy combining two immune checkpoint blockers, iparomlimab and tuvonralimab, with chemotherapy before surgery to treat patients with PD-L1-positive LACC. This phase II trial aims to assess the effectiveness and safety of this preoperative treatment approach. Participants will receive one cycle of combined treatment with iparomlimab, tuvonralimab, cisplatin, and nab-paclitaxel, all given intravenously. This is followed by two additional cycles of iparomlimab and tuvonralimab alone every three weeks. After completing three cycles, patients who respond well will undergo radical surgery. Depending on surgery results and guidelines, further treatment may be given, while those with stable or worsening disease will receive chemoradiotherapy. Throughout the study, participants will have regular evaluations including tumor measurements and lab tests. Researchers will measure responses up to surgery at three months, focusing on complete pathological response. Additional outcomes include survival rates up to two years and monitoring of side effects during the 12-month treatment period. The total study duration involves treatment, surgery, and follow-up assessments to understand treatment impact and safety.

Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)