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Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Sponsor: Hospital Israelita Albert Einstein
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.
Official title: Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 95 Years
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2022-08-30
Completion Date
2028-03-31
Last Updated
2024-01-05
Healthy Volunteers
No
Conditions
Interventions
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
Ipilimumab 200 MG in 40 ML Injection
Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to 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
Locations (14)
CRIO -Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Clinica AMO
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas da UFMG
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Multi Oncoclinicas Recife
Recife, Pernambuco, Brazil
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Federal de Roraima
Boa Vista, Roraima, Brazil
CEPON - Florianópolis
Florianópolis, Santa Catarina, Brazil
Hospital de Amor
Barretos, São Paulo, Brazil
Hospital De Base de São José do Rio Preto - CIP São José
São José do Rio Preto, São Paulo, Brazil
INCA - Instituto Nacional do Cancer
Rio de Janeiro, Brazil
AC Camargo Cancer Center
São Paulo, Brazil
Hospital Municipal Vila Santa Catarina
São Paulo, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil