Last updated 2 years 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 yearsDocumented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVANo prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancerWHO/ECOG performance status of 0-1At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion at baseline.
- Diagnosis of small cell (neuroendocrine) histology cervical cancerIntent to administer a fertility-sparing treatment regimenUndergone a previous hysterectomyEvidence 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 transplantationActive or prior documented autoimmune or inflammatory disordersUncontrolled intercurrent illnessHistory of another primary malignancy and active primary immunodeficiencyPatients with active infectionLaboratory 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
Centro Regional Integrado de Oncologia - CRIO
Recruiting
Hospital Das Clínicas Da Universidade Federal de Minas Gerais - UFMG
Recruiting
Hospital Erasto Gaertner
Recruiting
Multi Oncoclinicas Recife
Recruiting
INSCER - Instituto do Cérebro da PUC-RS
Recruiting
Universidade Federal de Roraima
Recruiting
Centro Pesquisas Oncologicas - CEPON
Recruiting
Faculdade de Medicina de São José do Rio Preto-SP (FAMERP) - Hospital de Base (HB)
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
StudyNivolumab
SponsorHospital Israelita Albert Einstein
Study typeInterventional
Conditions
Cervical cancer
Requirements
To 95 YearsFemale
Unique study IDclinicaltrials.gov
NCT05492123
