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NCT05492123
Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
Phase 2 trial testing Nivolumab 40 mg in 4 ml Injection in Uterine Cervical Neoplasms in 112 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Hospital Israelita Albert Einstein |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 30 August 2022 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 March 2028 |
| Sites | 14 locations across Brazil |
Drugs / interventions tested
- Nivolumab 40 mg in 4 ml Injection — full drug profile →
- Ipilimumab 200 MG in 40 ML Injection — full drug profile →
- Chemoradiation — full drug profile →
Conditions studied
- Uterine Cervical Neoplasms — all drugs for Uterine Cervical Neoplasms →
Sponsor
Hospital Israelita Albert Einstein
Who can join
Adults 18 to 95, female only, with Uterine Cervical Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in cervical cancer: current insights and future directions.
Xu M, Cao C, Wu P, Huang X, et al · · 2025 · cited 55× · PMID 39611440 · DOI 10.1002/cac2.12629 -
Human papillomavirus associated cervical lesion: pathogenesis and therapeutic interventions.
Ye J, Zheng L, He Y, Qi X. · · 2023 · cited 27× · PMID 37719443 · DOI 10.1002/mco2.368 -
Cervical cancer treatment update: A Society of Gynecologic Oncology clinical practice statement.
Girda E, Randall LM, Chino F, Monk BJ, et al · · 2023 · cited 18× · PMID 37980766 · DOI 10.1016/j.ygyno.2023.10.017 -
Recent advances in immunotherapy for cervical cancer.
Ogasawara A, Hasegawa K. · · 2025 · cited 13× · PMID 39888529 · DOI 10.1007/s10147-025-02699-0 -
The abscopal effect of immune-radiation therapy in recurrent and metastatic cervical cancer: a narrative review.
Ollivier L, Moreau Bachelard C, Renaud E, Dhamelincourt E, et al · · 2023 · cited 6× · PMID 37539054 · DOI 10.3389/fimmu.2023.1201675 -
The promise of PD1/PDL1 targeted immunotherapy in locally advanced cervical cancer: a game-changer for patients outcome?
Kouhen F, El Ghanmi A, Inghaoun H, Miftah H, et al · · 2025 · cited 3× · PMID 40433369 · DOI 10.3389/fimmu.2025.1573576 -
Bridging the Gap: Immune Checkpoint Inhibitor as an Option in the Management of Advanced and Recurrent Cervical Cancer in Sub-Saharan Africa.
Okpalanwaka IF, Anazodo FI, Chike-Aliozor ZL, Ekweozor C, et al · · 2024 · cited 2× · PMID 39398762 · DOI 10.7759/cureus.69136 -
Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568
Verify or expand the search:
- PubMed search for NCT05492123
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Nivolumab 40 mg in 4 ml Injection
Trials testing the same drug.
- NCT06188676 — Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunother · Phase 3 · recruiting
- NCT03343665 — Treatment With Nivolumab at the Fixed Dose 40 mg (Nivo40) in Patients With Relapsed/Refractory Hodgkins Lymphoma · Phase 1, PHASE2 · completed
Other recruiting trials for Uterine Cervical Neoplasms
Currently open trials in the same condition.
- NCT07305727 — A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer · recruiting
- NCT07011836 — Video-Based Patient Navigation to Support Cervical Cancer Screening Among Black Women · NA · recruiting
- NCT06815939 — Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer · NA · recruiting
- NCT06558682 — Neoadjuvant Therapy in Cervical Cancer · NA · recruiting
- NCT06509724 — Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy · Phase 3 · recruiting
Other Hospital Israelita Albert Einstein trials
Trials by the same sponsor.
- NCT07447674 — ED Post-Discharge Digital Follow-Up: A Communication Comparison · NA · not yet recruiting
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- NCT07233837 — Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units · NA · recruiting
- NCT06726707 — COPPER: A Trial Evaluating Copper-based Products for Incontinence-associated Dermatitis · Phase 2, PHASE3 · withdrawn
- NCT07112846 — Prospective Clinical Registry for Evaluation of Exanthematous Infections and Coinfections · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05492123 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Israelita Albert Einstein
- Last refreshed: 5 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05492123.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing