Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)
Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial
Fujian Cancer Hospital
43 participants
Aug 21, 2025
INTERVENTIONAL
Conditions
Summary
Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1/CTLA-4 dual blocker-combined with chemotherapy for LACC.
Eligibility
Inclusion Criteria15
- 、Written informed consent
- 、18-70 years old
- 、Adequate organ function and ECOG of 0 \~1
- 、Without systemic therapy at the time of enrollment
- 、FIGO 2018 stage IB3, IIA2, or IIIC1r
- 、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- 、Measurable lesions could be defined by RECIST v1.1
- 、Willing to get blood/ tumor tissue tested
- 、Patients who observed the rules about the scheduled visit, study schedule, and medical examination
- 、The function of major organs is normal, and the following criteria are met:
- Blood routine examination must meet: (no blood transfusion within 14 days)
- Hb≥90g/L:
- ANC≥1.5x10\^9/L; PLT≥100x10\^9/L;
- The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L
- 、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.
Exclusion Criteria10
- 、History of other malignancies within 3 years
- 、Participate in other clinical trials at the same time
- 、Active autoimmune disease, which needs systemic therapy
- 、Uncontrolled infection, which needs systemic therapy
- 、History of allogeneic tissue/solid organ transplant
- 、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc
- 、Active HBV, HCV, or HIV infection
- 、Pregnant or lactating female patients
- 、Drug or alcohol abuse
- 、 Unable or unwilling to sign the informed consent
Interventions
Neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab, cisplatin, and nab-paclitaxel for 1 cycle, then Iparomlimab and tuvonralimab continued for 2 cycles at 3-week intervals. Details: Iparomlimab and tuvonralimab 5 mg/kg, IV infusion, Q3W for 3 cycles Cisplatin：75-80 mg/m2, IV infusion, (cycle 1) Nab-paclitaxel 260 mg/m2，30min，IV infusion,(cycle 1)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07055399