Immune Drugs Added to Chemoradiation for Advanced Cervical Cancer
Tests nivolumab and ipilimumab before chemoradiation in adults with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Key facts
- Where
- Barretos, Belo Horizonte, Boa Vista, Curitiba, Florianópolis, Fortaleza, Porto Alegre, Recife, Rio de Janeiro, Salvador, São José do Rio Preto, and São Paulo, BrazilSee the 14 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 95 years old?
Source: NCT05492123, who can take part
Where in Brazil
- Hospital de AmorBarretos, BrazilNot yet recruiting
- Hospital das Clinicas da UFMGBelo Horizonte, BrazilNot yet recruiting
- Universidade Federal de RoraimaBoa Vista, BrazilTaking people
- Hospital Erasto GaertnerCuritiba, BrazilNot yet recruiting
- CEPON - FlorianópolisFlorianópolis, BrazilNot yet recruiting
- Crio - Centro Regional Integrado de OncologiaFortaleza, BrazilTaking people
- Hospital Sao Lucas - PUCRSPorto Alegre, BrazilNot yet recruiting
- Multi Oncoclinicas RecifeRecife, BrazilTaking people
- INCA - Instituto Nacional do CancerRio de Janeiro, BrazilNot yet recruiting
- Clinica AMOSalvador, BrazilTaking people
- Hospital De Base de São José do Rio Preto - CIP São JoséSão José do Rio Preto, BrazilNot yet recruiting
- AC Camargo Cancer CenterSão Paulo, BrazilNot yet recruiting
- Hospital Israelita Albert EinsteinSão Paulo, BrazilTaking people
- Hospital Municipal Vila Santa CatarinaSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Israelita Albert Einstein
- Trial code
- NCT05492123
- Record updated
- 5 January 2024
- Original description
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.Read full original descriptionShow less
Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer
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.
Inclusion: 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: Undergone a previous hysterectomy; Active or prior documented autoimmune or inflammatory disorders; Diagnosis of small cell (neuroendocrine) histology cervical cancer; 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; Uncontrolled intercurrent illness; History of another primary malignancy and active primary immunodeficiency; 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; 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); Intent to administer a fertility-sparing treatment regimen.