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OncoMatch/Clinical Trials/NCT05492123

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Is NCT05492123 recruiting? Yes, currently enrolling (Jun 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 Jun 2026Location: Brazil

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

Treatments studied

Immunotherapy

Nivolumab 40 mg in 4 ml

Other

Ipilimumab 200 MG in 40 ML

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

Demographics

Ages ≤ 95
Female only

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.

Frequently asked questions

Is NCT05492123 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage FIGO STAGE IB2-IB3 NODE POSITIVE or STAGE IIB-IVA is required.

Is there an age limit?

Yes. Patients must be 95 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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