drugset / Trial / NCT06942416

Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer

NCT06942416

Phase 2 Recruiting 36 enrolled Shandong Cancer Hospital and Institute
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic、tissue and stool samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.

Timeline

Start
2025-02-28
Primary completion
2026-07-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 300 mg/m2 Intravenous
Subject Carboplatin Small molecule 400 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Iparomlimab Monoclonal antibody 5 mg/kg Intravenous
Subject Paclitaxel Small molecule 135 mg/m2 Intravenous
Subject Tuvonralimab Monoclonal antibody 5 mg/kg Intravenous

Indications