RecruitingPhase 2NCT05492123

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


Sponsor

Hospital Israelita Albert Einstein

Enrollment

112 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — nivolumab and ipilimumab — added to standard chemoradiation (chemotherapy plus radiation) for women with locally advanced cervical cancer. Immunotherapy helps the immune system attack cancer cells. Researchers want to see if adding it to the standard treatment improves outcomes. **You may be eligible if...** - You are a woman over 18 with cervical cancer (adenocarcinoma or squamous carcinoma) - Your cancer is locally advanced (FIGO stage IB2–IB3 with lymph node spread, or stages IIB–IVA) - You have not received prior chemotherapy, immunotherapy, or radiation for cervical cancer - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have a rare small cell or neuroendocrine type of cervical cancer - You have already had a hysterectomy - You have distant metastases - You have active autoimmune disease or a history of organ transplant - You are pregnant or planning a fertility-sparing approach - You have had another primary cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab 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

DRUGIpilimumab 200 MG in 40 ML Injection

Ipilimumab 3mg/kg every 3 weeks for 4 cycles prior to radiation

RADIATIONChemoradiation

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

View Full Details on ClinicalTrials.gov

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NCT05492123


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