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
Study 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
FEMALE
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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:
1. WBC count (WBC) \< 2000/μL ;
2. Neutrophil count \< 1500/μL;
3. Platelet count \< 100 x 103/μL;
4. Hemoglobin level \< 9.0 g/dL;
5. 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);
6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): \> 3.0 x ULN;
7. Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 x ULN);
8. 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
Primary outcome measure(s)
3-year progression-free survival — 3 years No evidence of disease recurrence/regrowth after 3 years of follow-up
Trial sites (14)
Facility
City
Region
Status
CRIO -Centro Regional Integrado de Oncologia
Fortaleza
Ceará
Recruiting
Clinica AMO
Salvador
Estado de Bahia
Recruiting
Hospital das Clinicas da UFMG
Belo Horizonte
Minas Gerais
Not Yet Recruiting
Hospital Erasto Gaertner
Curitiba
Paraná
Not Yet Recruiting
Multi Oncoclinicas Recife
Recife
Pernambuco
Recruiting
Hospital São Lucas - PUCRS
Porto Alegre
Rio Grande do Sul
Not Yet Recruiting
Universidade Federal de Roraima
Boa Vista
Roraima
Recruiting
CEPON - Florianópolis
Florianópolis
Santa Catarina
Not Yet Recruiting
Hospital de Amor
Barretos
São Paulo
Not Yet Recruiting
Hospital De Base de São José do Rio Preto - CIP São José
São José do Rio Preto
São Paulo
Not Yet Recruiting
INCA - Instituto Nacional do Cancer
Rio de Janeiro
Brazil
Not Yet Recruiting
AC Camargo Cancer Center
São Paulo
Brazil
Not Yet Recruiting
Hospital Municipal Vila Santa Catarina
São Paulo
Brazil
Recruiting
Hospital Israelita Albert Einstein
São Paulo
Brazil
Recruiting
More Hospital Israelita Albert Einstein trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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