NCT05492123

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Uterine Cervical Neoplasms

Interventions

Type	Name	Description
DRUG	Nivolumab 40 mg in 4 ml Injection	Nivolumab 1mg/kg every 3 weeks for 4 cycles prior to radiation and 240mg every 2 weeks with concurrent radiation
DRUG	Ipilimumab 200 MG in 40 ML Injection	Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation
RADIATION	Chemoradiation	Radiation to a dose of 45Gy over 25 1.8Gyfractions and brachytherapy with concurrent weekly cisplatin 40mg/m2/w or carboplatin AUC 2/w

Timeline

• Start date: 2022-08-30
• Primary completion: 2026-12-31
• Completion: 2028-03-31
• First posted: 2022-08-08
• Last updated: 2024-01-05

Locations

14 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study