Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Uterine Cervical Neoplasms
About this trial
This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring Uterine Cervical Neoplasms, Nivolumab, Ipilimumab, Chemoradiation, Anti-PD1, Anti-PDL1, Anti-CTLA4, Immunotherapy
Eligibility Criteria
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:
- 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 / Locations
- Clinica AMO
- CRIO -Centro Regional Integrado de OncologiaRecruiting
- Hospital das Clinicas da UFMG
- Hospital Erasto Gaertner
- Multi Oncoclinicas RecifeRecruiting
- Hospital São Lucas - PUCRS
- Universidade Federal de RoraimaRecruiting
- CEPON - Florianópolis
- Hospital de Amor
- Hospital De Base de São José do Rio Preto - CIP São José
- INCA - Instituto Nacional do Cancer
- AC Camargo Cancer Center
- Hospital Municipal Vila Santa CatarinaRecruiting
- Hospital Israelita Albert EinsteinRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Chemoradiation
Immunotherapy
Traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week or carboplatin AUC 2/week
4 cycles of induction therapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks followed by traditional radiation therapy with a target of 45 Gy in 25 1.8Gy fractions with concurrent weekly cisplatin 40mg/m2/week (or carboplatin AUC 2/week) with concurrent nivolumab 240mg every 2 weeks.