Phase
Condition
Uterine Disorders
Cervical Cancer
Treatment
Ipilimumab 200 MG in 40 ML Injection
Nivolumab 40 mg in 4 ml Injection
Chemoradiation
Clinical Study ID
Ages 18-95 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female participants older than 18 years
- Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO StageIB2-IB3 node positive or Stage IIB-IVA
- No prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervicalcancer
- WHO/ECOG performance status of 0-1
- At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TargetLesion at baseline.
Exclusion
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 (shortaxis) 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 atotal bilirubin level of < 3.0 x ULN);
- Any positive test result for hepatitis B virus or hepatitis C virus that indicates thepresence of the virus, for example, positive Hepatitis B surface antigen (HBsAg,Australia antigen) or Hepatitis C antibodies (anti- HCV) positive (unless the HCV-RNAis negative).
- Participants with a condition requiring systemic treatment or withcorticosteroids (>10 mg daily of a prednisone equivalent) or otherimmunosuppressive drugs within 14 days of initiating study treatment.
- Pregnant or breastfeeding woman
Study Design
Study Description
Connect with a study center
Clinica AMO
Salvador, Bahia 41810-011
BrazilActive - Recruiting
CRIO -Centro Regional Integrado de Oncologia
Fortaleza, Ceará 60335-480
BrazilActive - Recruiting
Hospital das Clinicas da UFMG
Belo Horizonte, Minas Gerais 30130-100
BrazilSite Not Available
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
BrazilSite Not Available
Multi Oncoclinicas Recife
Recife, Pernambuco 50070-460
BrazilActive - Recruiting
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande Do Sul 90610-001
BrazilSite Not Available
Universidade Federal de Roraima
Boa Vista, Roraima 69310-000
BrazilActive - Recruiting
CEPON - Florianópolis
Florianópolis, Santa Catarina 88034-000
BrazilSite Not Available
Hospital de Amor
Barretos, São Paulo 14784-400
BrazilSite Not Available
Hospital De Base de São José do Rio Preto - CIP São José
São José Do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
INCA - Instituto Nacional do Cancer
Rio De Janeiro, 20230-130
BrazilSite Not Available
AC Camargo Cancer Center
São Paulo, 01509-001
BrazilSite Not Available
Hospital Israelita Albert Einstein
São Paulo, 05652-900
BrazilActive - Recruiting
Hospital Municipal Vila Santa Catarina
São Paulo, 04378-500
BrazilActive - Recruiting
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