Clinical trial · Interventional
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
NCT07055399CI-TRIAL-00094937NICE-CCrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group : iparomlimab and tuvonralimab plus nab-paclitaxel, cisplatin
- description
- Participants will receive iparomlimab and tuvonralimab at a dose of 5 mg/kg, nab-paclitaxel at 260 mg/m², and cisplatin at 75-80 mg/m², all administered intravenously on day 1. After three weeks, participants will continue with only iparomlimab and tuvonralimab(5 mg/kg) for two additional cycles at an interval of 3 weeks.
- interventionNames
- Drug: neoadjuvant chemo-immunotherapy: Iparomlimab and tuvonralimab plus cisplatin,nab-paclitaxel for 1 cycle and Iparomlimab and tuvonralimab for 2 cycles
Primary outcomes (1)
- measure
- Pathological complete response (pCR)
- timeFrame
- From enrollment to the end of surgery at 3 months
- description
- Pathological complete response（pCR） is defined as the absence of viable tumor cells by surgery
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1、Written informed consent * 2、18-70 years old * 3、Adequate organ function and ECOG of 0 \~1 * 4、Without systemic therapy at the time of enrollment * 5、FIGO 2018 stage IB3, IIA2, or IIIC1r * 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix * 7、Measurable lesions could be defined by RECIST v1.1 * 8、Willing to get blood/ tumor tissue tested * 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination * 10、The function of major organs is normal, and the following criteria are met: * 10.1 Blood routine examination must meet: (no blood transfusion within 14 days) Hb≥90g/L: ANC≥1.5x10\^9/L; PLT≥100x10\^9/L; * 10.2 The biochemical examination must meet the following standards BIL \< 1.5 × ULN; ALT and AST \< 2.5xULN; ALB≥ 28 g/L * 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures. Exclusion Criteria: * 1、History of other malignancies within 3 years * 2、Participate in other clinical trials at the same time * 3、Active autoimmune disease, which needs systemic therapy * 4、Uncontrolled infection, which needs systemic therapy * 5、History of allogeneic tissue/solid organ transplant * 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc * 7、Active HBV, HCV, or HIV infection * 8、Pregnant or lactating female patients * 9、Drug or alcohol abuse * 10、 Unable or unwilling to sign the informed consent
References
Publications (8)
- BACKGROUNDWu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16. PMID 39426385
- BACKGROUNDNederlof I, Isaeva OI, de Graaf M, Gielen RCAM, Bakker NAM, Rolfes AL, Garner H, Boeckx B, Traets JJH, Mandjes IAM, de Maaker M, van Brussel T, Chelushkin M, Champanhet E, Lopez-Yurda M, van de Vijver K, van den Berg JG, Hofland I, Klioueva N, Mann RM, Loo CE, van Duijnhoven FH, Skinner V, Luykx S, Kerver E, Kalashnikova E, van Dongen MGJ, Sonke GS, Linn SC, Blank CU, de Visser KE, Salgado R, Wessels LFA, Drukker CA, Schumacher TN, Horlings HM, Lambrechts D, Kok M. Neoadjuvant nivolumab or nivolumab plus ipilimumab in early-stage triple-negative breast cancer: a phase 2 adaptive trial. Nat Med. 2024 Nov;30(11):3223-3235. doi: 10.1038/s41591-024-03249-3. Epub 2024 Sep 16. PMID 39284953
- BACKGROUNDKeam SJ. Iparomlimab and Tuvonralimab: First Approval. Drugs. 2025 May;85(5):699-706. doi: 10.1007/s40265-025-02160-6. Epub 2025 Apr 1. PMID 40167968
- BACKGROUNDLi K, Chen J, Hu Y, Wang YZ, Shen Y, Chen G, Peng W, Fang Z, Xia B, Chen X, Song K, Wang Y, Zou D, Wang YC, Han Y, Feng X, Yuan J, Guo S, Meng X, Feng C, Chen Y, Yang J, Fan J, Wang J, Ai J, Ma D, Sun C. Neoadjuvant chemotherapy plus camrelizumab for locally advanced cervical cancer (NACI study): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2024 Jan;25(1):76-85. doi: 10.1016/S1470-2045(23)00531-4. Epub 2023 Dec 1. PMID 38048802
- Miriyala R, Mahantshetty U, Maheshwari A, Gupta S. Neoadjuvant chemotherapy followed by surgery in cervical cancer: past, present and future. Int J Gynecol Cancer. 2022 Mar;32(3):260-265. doi: 10.1136/ijgc-2021-002531.