Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Recruiting now · Phase 2

Conditions studied: Uterine Cervical Neoplasms

In brief

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.

Key facts

Study ID

NCT05492123

Run by

Hospital Israelita Albert Einstein

People needed

112

Starts

2022-08-30

Expected to finish

2028-03-31

Last updated by the study team

2024-01-05

Who can join

Age: 18 and older, up to 95. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CRIO -Centro Regional Integrado de Oncologia — Fortaleza, Ceará, Brazil (enrolling)
• Clinica AMO — Salvador, Estado de Bahia, Brazil (enrolling)
• Multi Oncoclinicas Recife — Recife, Pernambuco, Brazil (enrolling)
• Universidade Federal de Roraima — Boa Vista, Roraima, Brazil (enrolling)
• Hospital Municipal Vila Santa Catarina — São Paulo, Brazil (enrolling)
• Hospital Israelita Albert Einstein — São Paulo, Brazil (enrolling)
• AC Camargo Cancer Center — São Paulo, Brazil
• CEPON - Florianópolis — Florianópolis, Santa Catarina, Brazil
• Hospital de Amor — Barretos, São Paulo, Brazil
• Hospital De Base de São José do Rio Preto - CIP São José — São José do Rio Preto, São Paulo, Brazil
• Hospital das Clinicas da UFMG — Belo Horizonte, Minas Gerais, Brazil
• Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
• INCA - Instituto Nacional do Cancer — Rio de Janeiro, Brazil
• Hospital São Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil

Full record on ClinicalTrials.gov

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