NCT05492123 Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer
| NCT ID | NCT05492123 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2022-08-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 112 participants in total. It began in 2022-08-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Diagnosis of small cell (neuroendocrine) histology cervical cancer * Intent to administer a fertility-sparing treatment regimen * Undergone a previous hysterectomy * 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 * Active or prior documented autoimmune or inflammatory disorders * Uncontrolled intercurrent illness * History of another primary malignancy and active primary immunodeficiency * Patients with active infection Laboratory values that fall into: 1. WBC count (WBC) \< 2000/μL ; 2. Neutrophil count \< 1500/μL; 3. Platelet count \< 100 x 103/μL; 4. Hemoglobin level \< 9.0 g/dL; 5. 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); 6. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): \> 3.0 x ULN; 7. Total bilirubin \> 1.5 x ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \< 3.0 x ULN); 8. 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
Contact & Investigator
Fernando Maluf, MD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT05492123 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 95 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05492123 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05492123 currently recruiting?
Yes, NCT05492123 is actively recruiting participants. Contact the research team at diogo.gomes@einstein.br for enrollment information.
Where is the NCT05492123 trial being conducted?
This trial is being conducted at Fortaleza, Brazil, Salvador, Brazil, Belo Horizonte, Brazil, Curitiba, Brazil and 10 additional locations.
Who is sponsoring the NCT05492123 clinical trial?
NCT05492123 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Fernando Maluf, MD at Hospital Israelita Albert Einstein. The trial plans to enroll 112 participants.