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RECRUITING
NCT05492123
PHASE2

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Sponsor: Hospital Israelita Albert Einstein

View on ClinicalTrials.gov

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

Interventions

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

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