Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

Official title: Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer

Status Recruiting

Clinical Trial Summary

A total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. The primary outcome will be 3-year disease-free survival.

Clinical Trial Description

Patients with adenocarcinoma or squamous cell carcinoma of the cervix, FIGO Stage IB2-IB3 node positive or Stage IIB-IVA will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. Primary outcome will be 3-year progression-free survival. ;

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

• NCT number: NCT05492123
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Diogo Bugano, MD
• Phone: +55-11-2151-0240
• Email: diogo.gomes@einstein.br
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2022
• Completion date: March 31, 2028