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OncoMatch/Clinical Trials/NCT05492123

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Is NCT05492123 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab 40 mg in 4 ml and Ipilimumab 200 MG in 40 ML for uterine cervical neoplasms.

Phase 2RecruitingHospital Israelita Albert EinsteinNCT05492123Data as of May 2026

Treatment: Nivolumab 40 mg in 4 ml · Ipilimumab 200 MG in 40 MLA 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.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Disease stage

Required: Stage FIGO STAGE IB2-IB3 NODE POSITIVE, STAGE IIB-IVA (FIGO)

cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IB3 node positive or Stage IIB-IVA

Performance status

WHO/ECOG 0–1

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Cannot have received: immune checkpoint inhibitor

Cannot have received: radiation therapy

Lab requirements

Blood counts

WBC ≥ 2000/μL; Neutrophil count ≥ 1500/μL; Platelet count ≥ 100 x 10^3/μL; Hemoglobin ≥ 9.0 g/dL

Kidney function

Serum creatinine ≤ 1.5 x ULN unless creatinine clearance ≥ 40 mL/min

Liver function

AST/ALT ≤ 3.0 x ULN; Total bilirubin ≤ 1.5 x ULN (except Gilbert Syndrome: < 3.0 x ULN)

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; AST/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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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