Last reviewed · How we verify

NCT05492123

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer

Recruiting now Phase 2 Last updated 5 January 2024
What this trial tests

Phase 2 trial testing Nivolumab 40 mg in 4 ml Injection in Uterine Cervical Neoplasms in 112 participants. Currently enrolling.

Timeline
30 August 2022
Primary endpoint
31 December 2026
31 March 2028

Quick facts

Lead sponsorHospital Israelita Albert Einstein
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment112
Start date30 August 2022
Primary completion31 December 2026
Estimated completion31 March 2028
Sites14 locations across Brazil

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. Recent advances in immunotherapy for cervical cancer.
    Ogasawara A, Hasegawa K. · · 2025 · cited 13× · PMID 39888529 · DOI 10.1007/s10147-025-02699-0
  5. 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
  6. 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
  7. 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
  8. 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:

Other trials of Nivolumab 40 mg in 4 ml Injection

Trials testing the same drug.

Other recruiting trials for Uterine Cervical Neoplasms

Currently open trials in the same condition.

Other Hospital Israelita Albert Einstein trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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