Last updated 11 months ago

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

112 patients around the world

Available in Brazil

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.

Hospital Israelita Albert Einstein

14Research sites

112Patients around the world

This study is for people with

Cervical cancer

Requirements for the patient

To 95 Years

Female

Medical requirements

: Female participants older than 18 years
Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA
No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer
WHO/ECOG performance status of 0-1
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.

: Diagnosis of small cell (neuroendocrine) histology cervical cancer
Intent to administer a fertility-sparing treatment regimen
Undergone a previous hysterectomy
Evidence of metastatic disease per RECIST 1.1 including lymph nodes ≥15 mm (short axis) above the L1 cephalad body or outside the planned radiation field.
History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness
History of another primary malignancy and active primary immunodeficiency
Patients with active infection
Laboratory values that fall into:
WBC count (WBC) < 2000/μL ;
Neutrophil count < 1500/μL;
Platelet count < 100 x 103/μL;
Hemoglobin level < 9.0 g/dL;
Serum creatinine > 1.5 x upper limit of normal (ULN) unless creatinine clearance is ≥ 40 mL/min (measured or calculated using the Cockcroft-Gault formula);
Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): > 3.0 x ULN;
Total bilirubin > 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0 x ULN);
Any positive test result for hepatitis B virus or hepatitis C virus that indicates the presence of the virus, for example, positive Hepatitis B surface antigen (HBsAg, Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the HCV-RNA is negative).
Participants with a condition requiring systemic treatment or with corticosteroids (>10 mg daily of a prednisone equivalent) or other immunosuppressive drugs within 14 days of initiating study treatment.
Pregnant or breastfeeding woman

Sites

Clínica AMO

Recruiting

Salvador, Bahia, 41830-907

Centro Regional Integrado de Oncologia - CRIO

Recruiting

R. Francisco Calaça, 1300 - Álvaro Weyne, Fortaleza - CE, 60335-480

Hospital Das Clínicas Da Universidade Federal de Minas Gerais - UFMG

Recruiting

Av. Prof. Alfredo Balena, 110 2 floor - Room 216 - Santa Efigênia, Belo Horizonte - MG, 30130-100

Hospital Erasto Gaertner

Recruiting

Rua Joaquim Amaral - Cajuru, Curitiba - PR, 81520, Brazil

Multi Oncoclinicas Recife

Recruiting

Recife, Pernambuco, 50070-460

INSCER - Instituto do Cérebro da PUC-RS

Recruiting

Av. Ipiranga, 6690, 4o Andar, Centro de Pesquisa Clínica do HSLPUCRS - Jardim Botânico – Porto Alegre/RS - 90610-000

Universidade Federal de Roraima

Recruiting

Boa Vista, Roraima, 69310-000

Centro Pesquisas Oncologicas - CEPON

Recruiting

655 Rio Itacorubi Florianópolis SC BR 88034-000, Rod. Admar Gonzaga - Itacorubi, Florianópolis - SC

Hospital de Amor

Recruiting

Barretos, São Paulo, 14784-400

Hospital De Base de São José do Rio Preto - CIP São José

Recruiting

São José Do Rio Preto, São Paulo, 15090-000

SponsorHospital Israelita Albert Einstein

Study typeInterventional

Conditions

Cervical cancer

Requirements

To 95 YearsFemale

Unique study IDclinicaltrials.gov

NCT05492123